Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instrumentsOrthopaedic endoscopy instruments
Orthopaedic endoscopy instruments - other
EMDN code Z12021199
Manufacturers registered in Europe (EUDAMED) 11
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 142
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Olympus Medical Systems Corp. Present in Europe in other categories | Japan | Single Use Preloaded Sphincterotome V Single Use 3-Lumen Sphincterotome V Single Use Preloaded Sphincterotome V(Distal Wireguided) Single Use Sphincterotome V(Distal Wireguided) Single Use Preloaded Sphincterotome V (Distal Wireguided) Single Use Electrosurgical Knife | K252889 (2025) |
| Micro-Tech (Nanjing) Co., Ltd. | China | Sterile Sphincterotome Sphincterotome / short-wire compatible Sphincterotome short-wire compatible Single Use Electrosurgical Knife Guidewire Locking Device | K220247 (2022) |
| Boston Scientific Corp Present in Europe in other categories | United States | OrcaPod™ ORISE™ ProKnife Axios™ TRUEtome Jag 44 rezum Generator Hydratome RX 49 | K262460 (2026) |
| Ga Health Company Limited | China | andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit andorate® 4-piece valve kit andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit andorate® 3-piece Valve Kit andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit | K232118 (2023) |
| Cook, Inc. | United States | Cook Fusion Acusnare D.A.S.H. Tri-Tome pc | K181712 (2018) |
| Hangzhou AGS MedTech Co., Ltd. Present in Europe in other categories | China | – | K241704 (2025) |
| Günter Bissinger Medizintechnik GmbH Present in Europe in other categories | Germany | Guenter Bissinger Medizintechnik GmbH | registered |
| MEDIVATORS INC. Present in Europe in other categories | United States | ENDOGATOR Kit ENDOGATOR EndoGator Hybrid ENDOGATOR hybrid irrigation tubing | K231418 (2023) |
| Beijing ZKSK Technology Co.,Ltd Present in Europe in other categories | China | ZKSK | K242192 (2025) |
| SML Med-Tech Solutions Limited Present in Europe in other categories | China | CeroFrict | K220884 (2023) |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd Present in Europe in other categories | China | Clean Connecting Tube Disposable Endoscopy Adapter Sets Water Jet Adapter Disposable Endoscopy Adapter Set Disposable Biopsy Valve Disposable Endoscopy Valve Set | K250732 (2025) |
| US Endoscopy | United States | BioShield Torrent Padlock Clip Reveal Fuji 700 4-piece Valve Kit DEFENDO | registered |
| Micro-tech Usa | United States | 4-Piece Valve Kit 3-Piece Valve Kit Irrigation Tubing Set Air/Water Bottle Tubing Jacket Biopsy Valve Air/Water Bottle CO2 Tubing | registered |
| DIVERSATEK HEALTHCARE, INC. Present in Europe in other categories | United States | BullDog® BullDog Diversatek Healthcare PureFlo | K222734 (2022) |
| Merit Medical Systems, Inc. Present in Europe in other categories | United States | Brighton™ Bipolar Coagulation Probe Bipolar Hemostatic Probe QuickSilver™ Single Plug Bipolar Hemostasis Probe, 7Fr Dual Plug Bipolar Hemostasis, Probe, 7FR | K102273 (2010) |
| Olympus Winter & Ibe GmbH Present in Europe in other categories | Germany | Olympus | registered |
| Erbe Medical, LLC | United States | ERBEFLO® 2 ERBEFLO CleverCap® ERBEFLO AeroRinse® ERBEFLO® | registered |
| Starmed Co., Ltd. Present in Europe in other categories | South Korea | ELRA Electrode | K233113 (2023) |
| Pentax of America, Inc. Present in Europe in other categories | United States | ENDO-GATOR IRRIGATOR/INSUFFLATOR | K232249 (2023) |
| Finemedix Co., Ltd. | South Korea | ClearCap Distal Attachment | K242134 (2024) |
| CIPHER SURGICAL LIMITED Present in Europe in other categories | United Kingdom | CS-05-30-315 OpClear Disposable CS-10-30-315 OpClear Disposable CS-CU15-03 OpClear Control Unit CS-05-30-300 OpClear Disposable CS-05-00-290 OpClear Disposable CS-10-00-315 OpClear Disposable | K221824 (2022) |
| ENDO-THERAPEUTICS, INC. | United States | ezSnare Polypectomy Snare BioCeps Biopsy Forceps | K031026 (2003) |
| Smartdata Suzhou Co., Ltd. | China | Andorate Andorate® AquaPulse | K191366 (2019) |
| Zhejiang Chuangxiang Medical Technology Co., LTD. | China | Disposable Biopsy Valve Endoscopy Irrigation Tubing Air/Water Bottle Tubing Disposable Valve Sets | K230773 (2023) |
| Francis Medical, Inc. | United States | Vanquish Water Vapor Ablation System | K252388 (2025) |
| Taewoong Medical Co., Ltd. | South Korea | Sphincterotome Cystotome Optimos™ Cystotome | K260962 (2026) |
| AMERICAN MEDICAL ENDOSCOPY, INC. | United States | Strauss Surgical | registered |
| Creo Medical, Ltd. Present in Europe in other categories | United Kingdom | CROMA Electrosurgical Generator Speedboat Notch Long SpydrBlade Flex Footswitch Speedboat Ultraslim Long Speedboat UltraSlim Short | K242774 (2025) |
| Gyrus Acmi, Inc. Present in Europe in other categories | United States | BiCOAG GYRUS ACMI IRRI-FLO I IRRI-FLO II CleverLock | K092571 (2010) |
| Nissha Medical Technologies Present in Europe in other categories | United States | ELUXEO Tubing ELUXEO Tubing Kit ELUXEO Hybrid Tubing Kit ELUXEO Hybrid Tubing | K203350 (2021) |
| KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED | United Kingdom | Olympus | K193250 (2020) |
| Karl Storz GmbH & Co. KG Present in Europe in other categories | Germany | n.a. ENDOMAT | registered |
| Promepla Present in Europe in other categories | Monaco | RocaFlow Irrigation warming System Endoflow II US – Double Chamber Endoflow II US - Single Chamber ROCAFLOW Irrigation, Warming and Suction System RocaFlow - Irrigation, Warming and Suction System - Double Chamber RocaFlow II - Simple Chamber | registered |
| Hobbs Medical, Inc. | United States | Hobbs Medical TouchSoft Coagulator Hobbs Medical Mistifier Spray Catheter Hobbs Aspiration Catheter CleanCapture Aspiration Catheter Hobbs Medical Looped Retriever | K241874 (2024) |
| Coopersurgical, Inc. Present in Europe in other categories | United States | Redfield Redfield IRC 2100 REDFIELD CORPORATION | K990852 (1999) |
| SB-KAWASUMI LABORATORIES, INC. Present in Europe in other categories | Japan | SB Knife /Short type SB Knife Jr2 /Long type SB Knife /Standard type SB Knife Jr2 SB Knife /Jr type - Long SB Knife /Jr type | K241855 (2025) |
| Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory) Present in Europe in other categories | – | Disposable Endoscope Valves Kit | registered |
| Changzhou Endoclean Medical Device Co., Ltd. | China | Endoclean | K232244 (2023) |
| Telemed Systems, Inc. Present in Europe in other categories | United States | Disposable Papillotome/Sphincterotome | K992402 (1999) |
| OBP CORPORATION | – | ENDOSCOPIC SEAL SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO | registered |
| Smart Medical Systems , Ltd. | Israel | NaviAid™ AB NaviAid™ SPARK NaviAid™ ABC | K112106 (2012) |
| Aesculap, Inc. Present in Europe in other categories | United States | AESCULAP | K944955 (1994) |
| Anrei Medical(HZ) Co.,Ltd. | – | Medtronic Anrei | registered |
| Biotex, Inc. | United States | Bayou™ troCarWash System Disposable Kit Bayou™ troCarWash System Controller | K233442 (2024) |
| Erbe Elektromedizin GmbH Present in Europe in other categories | Germany | ERBE | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | MEDLINE Medline Industries, Inc. | K131426 (2014) |
| Ovesco Endoscopy AG | Germany | colonic FTRD Set diagnostic FTRD Set gastroduodenal FTRD Set | K242586 (2025) |
| Ruhof Corporation | United States | Ruhof Scope Valet Guardian ScopeValet Guardian Disposable Endoscope Valves with Cleaning Adapter | K122417 (2013) |
| WILSON INSTRUMENTS (SHANGHAI) CO., LTD. | China | HEYINOVO | K151714 (2015) |
| Chongqing Jinshan Science & Technology (Group) Co., Ltd | China | BEAMER AVEO IRRIGATION PUMP BOTTLE HOLDER (US/EU) REPLACEMENT PART BEAMER AVEO IRRIGATION PUMP HEAD REPLACEMENT PART | K210618 (2021) |
| ENDOSTART SRL | Italy | Endorail System Endorail Set | K232327 (2024) |
| Endosound, Inc. | United States | EndoSound® Biopsy Port Adapter (5 pack) 5064 EndoSound® Biopsy Port Adapter 5054 | K250145 (2025) |
| FUJIFILM medwork GmbH | Germany | FUJIFILM medwork | K221264 (2022) |
| HOYA CORPORATION | United States | PENTAX Medical | registered |
| Well Lead Medical Co.,Ltd | China | Wellead | K211814 (2022) |
| Applied Medical Resources Present in Europe in other categories | United States | Surseal® II | registered |
| C.R. Bard, Inc. | United States | Bard® Syringe Assist Irrigation System | K905102 (1991) |
| C2 Therapeutics, Inc. | United States | BOA Endoscopic Valve | K152140 (2015) |
| CENTERPOINT SYSTEMS LLC | United States | Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps | registered |
| Cameron-Miller, Inc. | United States | CAMERON-MILLER | registered |
| Jiangsu Vedkang Medical Science and Technology Co.,Ltd. Present in Europe in other categories | China | Disposable Sphincterotome | K232825 (2024) |
| LAMIDEY NOURY MEDICAL Present in Europe in other categories | France | Electrosurgical Unit MCB | K222542 (2022) |
| Nxthera, Inc. | United States | rezum | K180237 (2018) |
| AD Supply Group Limited | United Kingdom | – | registered |
| ATL Technology LLC | United States | – | registered |
| Alton (Shanghai) Medical Instruments Co., Ltd. | China | – | K241285 (2024) |
| Anrei Medical (Hangzhou) Co., Ltd. | China | – | K212999 (2022) |
| Aptyx | United States | – | registered |
| Apyx Medical Corporation Present in Europe in other categories | United States | – | registered |
| Aqua Medical, Inc. | United States | – | K251226 (2025) |
| B.Braun Medical, Inc. Present in Europe in other categories | United States | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CHG-MERIDIAN CANADA LTD | Canada | – | registered |
| CME Devices Ltd | United Kingdom | – | registered |
| COOK ENDOSCOPY | United States | – | registered |
| Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. Present in Europe in other categories | China | – | registered |
| Cirtec Medical Corporation | United States | – | registered |
| Covidien, LLC Present in Europe in other categories | United States | – | K173559 (2018) |
| DIMEDA INSTRUMENTE GMBH | Germany | – | registered |
| Dyne Medical Group, Inc. | South Korea | – | K252933 (2026) |
| Emcision , Ltd. | United Kingdom | – | K180165 (2018) |
| Endochoice, Inc. | United States | – | K161167 (2016) |
| Erbe USA, Inc. | United States | – | K221177 (2022) |
| FOREFRONT MEDICAL TECHNOLOGY (JIANGSU) CO.,LTD | China | – | registered |
| Freudenberg Medical, LLC | United States | – | registered |
| Fujifilm Corporation Present in Europe in other categories | Japan | – | registered |
| G-Flex Europe Sprl | Belgium | – | K211909 (2022) |
| GA Health Vietnam Company Limited | Vietnam | – | registered |
| GRACE MANUFACTURING, INC. | United States | – | registered |
| Gebruder Renggli AG | Switzerland | – | registered |
| Guenter Bissinger Medizintechnik GmbH | Germany | – | registered |
| HOYA Corporation PENTAX Division | United States | – | registered |
| Hangzhou Fushan Medical Appliance Co., Ltd. | China | – | registered |
| Hebei Lufen Tech Co., Limited | China | – | registered |
| Horizons Intl. Corp. | United States | – | K002236 (2001) |
| Ian Jamieson Pty Ltd | Australia | – | registered |
| KARL STORZ Endoscopy-America, Inc. | United States | – | K031457 (2004) |
| KOSCHER & WUERTZ GMBH | Germany | – | registered |
| Lake Region Medical | United States | – | registered |
| MDTGlobal, a.s. | Slovakia | – | registered |
The 100 most active manufacturers are shown, out of 142.
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