KNS · Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Gastroenterology, Urology · 21 CFR 876.4300 · Class 2
Overview
| Product Code | KNS |
|---|---|
| Device Name | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
| Regulation | 21 CFR 876.4300 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.
Classification Rationale
Class II (performance standards).
Cleared Devices (187)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252388 | Vanquish Water Vapor Ablation Device | Francis Medical, Inc. | Nov 26, 2025 | SESE |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation | Nov 25, 2025 | SESE |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | Olympus Medical Systems Corp. | Oct 17, 2025 | SESE |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | Olympus Medical Systems Corporation | Oct 10, 2025 | SESE |
| K251104 | SureTome SW Sphincterotome with DomeTip | Wilson-Cook Medical | Sep 29, 2025 | SESE |
| K251226 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | Aug 8, 2025 | SESE |
| K250584 | Rezum System | Boston Scientific Corporation | Jun 11, 2025 | SESE |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical, Ltd. | Jun 6, 2025 | SESE |
| K241855 | SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. | Mar 26, 2025 | SESE |
| K242192 | Disposable Sphincterotome | Beijing Zksk Technology Co., Ltd. | Feb 6, 2025 | SESE |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. | Jan 17, 2025 | SESE |
| K241271 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | Dec 12, 2024 | SESE |
| K242061 | Reusable Interface Cable 1.5 m (PRD-IFC-002) | Creo Medical, Ltd. | Aug 15, 2024 | SESE |
| K232825 | Disposable Sphincterotome | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Mar 29, 2024 | SESE |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific | Nov 28, 2023 | SESE |
| K232476 | Disposable Sphincterotome | Zhejiang Soudon Medical Technology Co., Ltd. | Nov 7, 2023 | SESE |
| K230328 | Speedboat Flush SB1 Instrument | Creo Medical, Ltd. | Oct 31, 2023 | SESE |
| K233318 | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) | Boston Scientific Corporation | Oct 27, 2023 | SESE |
| K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) | Starmed Co., Ltd. | Oct 25, 2023 | SESE |
| K232162 | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome | Boston Scientific Corporation | Aug 14, 2023 | SESE |
| K231533 | Habib EndoHPB | Boston Scientific Corporation | Jun 21, 2023 | SESE |
| K222421 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | May 3, 2023 | SESE |
| K223256 | Optimos Cystotome | Taewoong Medical Co., Ltd. | Apr 5, 2023 | SESE |
| K222542 | MCB UNIT Model: V10GMCBUS | Lamidey Noury Medical | Sep 21, 2022 | SESE |
| K211909 | Cysto-Gastro-Sets | G-Flex Europe Sprl | Jun 9, 2022 | SESE |
| K212999 | Multi-Functional Electrosurgical Knife | Anrei Medical (Hangzhou) Co., Ltd. | Mar 21, 2022 | SESE |
| K213627 | RF Vapor System | Aqua Medical, Inc. | Dec 17, 2021 | SESE |
| K210934 | Sphincterotome / short-wire compatible, Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | Dec 1, 2021 | SESE |
| K211282 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | May 27, 2021 | SESE |
| K201121 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | Feb 5, 2021 | SESE |
| K200404 | ORISE ProKnife | Boston Scientific Corporation | Dec 3, 2020 | SESE |
| K192342 | Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) | Hangzhou AGS MedTech Co., Ltd. | May 21, 2020 | SESE |
| K192905 | Creo Electrosurgical System with HS1 Hemostasis Accessory | Creo Medical, Ltd. | Mar 19, 2020 | SESK |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | Wilson-Cook Medical, Inc. | Jan 30, 2020 | SESE |
| K193039 | Single Use Balloon Dilator V (with knife) | Olympus Medical Systems Corp. | Dec 17, 2019 | SESE |
| K191505 | Rezum System | Nxthera (A Boston Scientific Company) | Aug 2, 2019 | SESE |
| K183595 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | Jun 21, 2019 | SESE |
| K182408 | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 | Olympus Medical Systems Corp. | May 15, 2019 | SESE |
| K190621 | SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long | Sumitomo Bakelite Co., Ltd. | Apr 23, 2019 | SESE |
| K181758 | ELRA Electrode | Starmed Co., Ltd. | Apr 11, 2019 | SESE |
| K190093 | Rezum Delivery Device, Rezum Generator | Nxthera (A Boston Scientific Company) | Mar 25, 2019 | SESE |
| K172665 | Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords | Wilson-Cook Medical Inc./Cook Endoscopy | May 24, 2018 | SESE |
| K172288 | Fusion OMNI Sphincterotome | Wilson-Cook Medical Inc./Cook Endoscopy | Apr 17, 2018 | SESE |
| K180165 | Habib EndoHPB | Emcision , Ltd. | Mar 20, 2018 | SESE |
| K180237 | Rezum System | Nxthera, Inc. | Feb 27, 2018 | SESE |
| K173559 | Barrx SB RFA Endoscopic Catheter | Covidien, LLC | Jan 18, 2018 | SESE |
| K171158 | Single Use Electrosurgical knife | Olympus Medical Systems Corp. | Nov 17, 2017 | SESE |
| K171993 | Zimmon Needle Knife Papillotome | Wilson-Cook Medical Inc./Cook Endoscopy | Aug 17, 2017 | SESE |
| K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory | Creo Medical, Ltd. | Aug 17, 2017 | SESE |
| K152771 | SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long | Sumitomo Bakelite Co., Ltd. | Jun 17, 2016 | SESE |
| K160417 | Rezum System | Nxthera, Inc. | Mar 17, 2016 | SESE |
| K160241 | Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 | Olympus Medical Systems Corp. | Mar 2, 2016 | SESE |
| K150142 | Single Use Balloon Dilator V (with Knife) | Olympus Medical Systems Corp. | Oct 8, 2015 | SESE |
| K150786 | Rezum System | Nxthera, Inc. | Aug 27, 2015 | SESE |
| K141991 | SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP | Olympus Medical Systems Copr. | Mar 31, 2015 | SESE |
| K133933 | INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER | Boston Scientific Corporation | Apr 2, 2014 | SESE |
| K130623 | BARRX CHANNEL RFA ENDOSCOPIC CATHETER | Covidien, LLC | Jul 26, 2013 | SESE |
| K122505 | SINGLE USE PRELOADED SPHINCTEROTOME V | Olympus Medical Systems Corp. | Apr 11, 2013 | SESE |
| K123319 | GYRUS ACMI BICOAG HEMOSTASIS PROBE | Olympus Surgical Technologies America | Dec 14, 2012 | SESE |
| K122203 | TRUETOME | Boston Scientific Corp | Aug 17, 2012 | SESE |
| K110887 | INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER | Boston Scientific Corporation | Apr 14, 2011 | SESE |
| K092571 | GYRUS ACMI BIOCOAG PROBE | Gyrus Acmi, Inc. | Oct 20, 2010 | SESE |
| K102273 | MERIT BIPOLAR COAGULATION PROBE | Merit Medical Systems, Inc. | Sep 7, 2010 | SESE |
| K093079 | TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U | Hobbs Medical, Inc. | Aug 2, 2010 | SESE |
| K101139 | PROSTIVA RF THERAPY MODEL 8929 HAND PIECE | Medtronic, Inc. | May 21, 2010 | SESE |
| K092309 | SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L | Olympus Medical Systems Corporation | Oct 30, 2009 | SESE |
| K083292 | HABIB ENDOHPB | Emcision , Ltd. | Jun 10, 2009 | SESE |
| K083275 | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 | Max Endoscopy, Inc. | Jun 9, 2009 | SESE |
| K082114 | ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 | Apollo Endosurgery, Inc. | Dec 19, 2008 | SESE |
| K082464 | PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 | Medtronic, Inc. | Oct 27, 2008 | SESE |
| K080946 | CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX | Conmed Endoscopic Technologies, Inc. | May 20, 2008 | SESE |
| K072383 | HABIB ENDOBLATE | Emcision , Ltd. | Nov 29, 2007 | SESE |
| K061684 | MEDI-GLOBE ROTA-CUT SPHINCTEROTOME | Medi-Globe Corporation | Jun 27, 2006 | SESE |
| K052413 | TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 | Medtronic Vascular | Nov 17, 2005 | SESE |
| K052051 | OMNI SPHINCTEROTOME | Wilson-Cook Medical, Inc. | Aug 5, 2005 | SESE |
| K050578 | COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE | Cook Ireland, Ltd. | Apr 22, 2005 | SESE |
| K033135 | STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM | Stryker Endoscopy | Aug 9, 2004 | SESE |
| K040981 | USW NEEDLEKNIFE PAPILLOTOME | Wilson-Cook Medical, Inc. | May 7, 2004 | SESE |
| K033203 | WILSON-COOK TRI-TOME SELECT PLUS | Wilson-Cook Medical, Inc. | Dec 19, 2003 | SESE |
| K031026 | ETI BIPOLAR HEMOSTATIC PROBE | Endo-Therapeutics, Inc. | Jun 27, 2003 | SESE |
| K030194 | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT | The Olympus Optical Co. | Mar 24, 2003 | SESE |
| K030315 | MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM | Ultroid, LLC | Feb 27, 2003 | SESE |
| K023706 | ULTROID HEMORRHOID MANAGEMENT SYSTEM | Ultroid, LLC | Jan 14, 2003 | SESE |
| K022595 | WILSON-COOK CYSTOTOME | Wilson-Cook Medical, Inc. | Oct 17, 2002 | SESE |
| K021266 | ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 | Ethicon Endo-Surgery, Inc. | Sep 27, 2002 | SESE |
| K012587 | RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE | Vidamed, Inc. | Dec 11, 2001 | SESE |
| K013153 | AUTOTOME RX MODEL # 4515, 4516 | Boston Scientific Corp | Oct 19, 2001 | SESE |
| K011787 | PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE | Vidamed, Inc. | Jul 6, 2001 | SESE |
| K010568 | ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM | Arthrocare Corp. | Mar 27, 2001 | SESE |
| K002583 | TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM | Vidamed, Inc. | Feb 13, 2001 | SESE |
| K002236 | HORIZONS PAPILLOTOME | Horizons Intl. Corp. | Jan 23, 2001 | SESE |
| K003569 | PLASMAKINETIC ENDOUROLOGY SYSTEM | Gyrus Medical , Ltd. | Dec 19, 2000 | SESE |
| K002802 | RAPID EXCHANGE TAPERTOME | Boston Scientific Corp | Oct 5, 2000 | SESE |
| K000508 | THERMOFLEX SYSTEM | Argomed, Inc. | Apr 18, 2000 | SESE |
| K994166 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE | Gyrus Medical , Ltd. | Dec 27, 1999 | SESE |
| K992402 | 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH | Telemed Systems, Inc. | Dec 22, 1999 | SESE |
| K991847 | THERMOFLEX SYSTEM | Argomed, Inc. | Aug 26, 1999 | SESE |
| K990628 | GYRUS ENDOUROLOGY SYSTEM | Gyrus Medical , Ltd. | Jun 29, 1999 | SESE |
| K990852 | COOPERSURGICAL INFRARED COAGULATOR | CooperSurgical, Inc. | Jun 11, 1999 | SESE |
| K990850 | COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL | CooperSurgical, Inc. | Jun 1, 1999 | SESE |
| K990376 | BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME | Ballard Medical Products | May 3, 1999 | SESE |
| K990855 | COOPERSURGICAL INFRARED COAGULATOR FOR ENT | CooperSurgical, Inc. | Mar 30, 1999 | SESE |
| K990145 | WILSON-COOK BIPOLAR PROBE | Wilson-Cook Medical, Inc. | Mar 25, 1999 | SESE |
| K982557 | BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES | Bard Interventional Products Div. | Sep 10, 1998 | SESE |
| K982289 | HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## | Olympus America, Inc. | Aug 19, 1998 | SESE |
| K974168 | COOPERSURGICAL INFRARED COAGULATOR | Hogan & Hartson | Jan 23, 1998 | SESE |
| K973826 | SPHINCTEROTOME | Boston Scientific Corp | Dec 5, 1997 | SESE |
| K973366 | COBRA HAND PIECE | Vidamed, Inc. | Nov 26, 1997 | SESE |
| K972674 | WILSON-COOK NEEDLE KNIFE PAPILLOTOME | Wilson-Cook Medical, Inc. | Aug 15, 1997 | SESE |
| K970945 | ANGLED TIP POLYPECTOMY SNARE | United States Endoscopy Group, Inc. | May 7, 1997 | SESE |
| K970278 | MICROVASIVE GOLD PROBE | Boston Scientific Corp | Apr 11, 1997 | SESE |
| K970053 | ULTRATOMERX | Boston Scientific Corp | Mar 28, 1997 | SESE |
| K963484 | BARD HIGH FLOW PAPILLOTOME | Bard Interventional Products Div. | Nov 19, 1996 | SESE |
| K962083 | KARL STORZ REMORGIDA FORCEPS | KARL STORZ Endoscopy-America, Inc. | Nov 1, 1996 | SESE |
| K962346 | PAPILLOTOME | United States Endoscopy Group, Inc. | Aug 8, 1996 | SESE |
| K960231 | SPHINCTEROTOME | Lighthouse Medical, Inc. | Jul 31, 1996 | SESE |
| K961762 | REUSABLE ENDOSCOPIC ACCESSORY HANDLE | United States Endoscopy Group, Inc. | Jul 22, 1996 | SESE |
| K961349 | INJECTION GOLD PROBE | Boston Scientific Corp | May 15, 1996 | SESE |
| K955247 | OLYMPUS KD SERIES SPHINCTEROTOME | Olympus America, Inc. | Apr 30, 1996 | SESE |
| K946109 | CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS | Cabot Medical Corp. | Nov 21, 1995 | SESE |
| K943629 | GIP/MEDI-GLOBE PAPILLOTOME | Medi-Globe Corp. | May 26, 1995 | SESE |
| K950836 | REDFIELD INFRARED COAGULATOR | Hogan & Hartson | Mar 24, 1995 | SESE |
| K950166 | OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE | Olympus America, Inc. | Feb 22, 1995 | SESE |
| K945764 | HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP | Aaron Medical Industries | Jan 30, 1995 | SESE |
| K944955 | AESCULAP THORACOSCOPIC INSTRUMENTS | Aesculap, Inc. | Nov 9, 1994 | SESE |
| K942301 | MICROVASIVE INJECTION GOLD PROBE | Boston Scientific Corp | Nov 2, 1994 | SESE |
| K932293 | CABOT MEDICAL BIPOLAR CUTTING FORCEPS | Cabot Medical Corp. | Jul 27, 1994 | SESE |
| K941728 | MONOPOLAR COAGULATING POLYPECTOMY SNARE | Endoscopic Innovations, Inc. | Jun 27, 1994 | SESE |
| K942068 | AMERICAN CATHETER SPHINCTEROTOME | Intl. Medical, Inc. | Jun 24, 1994 | SESE |
| K934315 | ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME | Endovations | Feb 28, 1994 | SESE |
| K921029 | DOBBHOFF BIPOLAR ADAPTER | Biosearch Medical Products, Inc. | May 6, 1992 | SESE |
| K920089 | MONOPOLAR COAGULATING POLYPECTOMY SNARE | Everest Medical Corp. | Mar 31, 1992 | SESE |
| K915408 | BIPOLAR ENDOSTASIS PROBE, BEST (TM) | Medical Devices, Inc. | Mar 11, 1992 | SESE |
| K913881 | ENDOSTAT ELECTROSURGICAL UNIT | Medical and Scientific Enterprises, Inc. | Nov 1, 1991 | SESE |
| K912129 | DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE | Biosearch Medical Products, Inc. | Aug 7, 1991 | SESE |
| K911648 | REDFIELD INFRARED COAGULATOR | Redfield Corp. | Jul 11, 1991 | SESE |
| K911600 | ILCO INFRARED LIGHT COAGULATOR | Holl Meditronics, Inc. | Jul 9, 1991 | SESE |
| K911700 | MONOPOLAR POLLYPECTOMY SNARE | Everest Medical Corp. | Jul 1, 1991 | SESE |
| K912601 | BIPROBE(TM) | C.R. Bard, Inc. | Jun 20, 1991 | SESE |
| K903323 | RESECTOSCOPE LOOPS | Olympus Corp. | Oct 1, 1990 | SESE |
| K901443 | ZIMMON PAPILLOTOME | Wilson-Cook Medical, Inc. | Jun 18, 1990 | SESE |
| K896612 | DOBBHOFF(R) PAPILLOTOME | Biosearch Medical Products, Inc. | Feb 12, 1990 | SESE |
| K896507 | PORGES DIATHERMY SNARE | Porges Corp. | Jan 29, 1990 | SESE |
| K896426 | PORGES SPHINCTEROTOMES | Porges Corp. | Jan 22, 1990 | SESE |
| K895855 | PHOENIX | Medical and Scientific Enterprises, Inc. | Jan 22, 1990 | SESE |
| K895842 | BITOME(TM) BIPOLAR SPHINCTEROTOME | Everest Medical Corp. | Jan 11, 1990 | SESE |
| K894861 | WILTEK PAPILLOTOME | Wiltek Medical, Inc. | Dec 21, 1989 | SESE |
| K892895 | MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM | Everest Medical Corp. | Sep 25, 1989 | SESE |
| K884025 | CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200 | Circon Acmi | Mar 3, 1989 | SESE |
| K885005 | MICROVASIVE GOLD PROBE | Boston Scientific Corp | Feb 1, 1989 | SESE |
| K884254 | CIRCON ACMI BICAP III THERAPEUTIC SYSTEM | Circon Acmi | Jan 11, 1989 | SESE |
| K884252 | CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20 | Circon Acmi | Jan 10, 1989 | SESE |
| K884306 | BICAP ABLATING FORCEPS BAF-7 | Circon Acmi | Jan 5, 1989 | SESE |
| K882048 | MEDITRON ENDOLAV MODEL EL-100 | Xylog Corp. | Oct 31, 1988 | SESE |
| K880748 | BALL TIP FULGURATING ELECTRODE, 3 FRENCH | Cook Urological, Inc. | Aug 4, 1988 | SESE |
| K870705 | THERMAL COAGULATOR | Microvasive | Apr 17, 1987 | SESE |
| K864413 | MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE | Cooper Lasersonics, Inc. | Dec 9, 1986 | SESE |
| K861904 | HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE | Cooper Lasersonics, Inc. | Oct 16, 1986 | SESE |
| K860593 | ET/RT PAPILLOTOME | Hobbs Medical, Inc. | Jul 22, 1986 | SESE |
| K862060 | POLYPECTOMY SNARE | Endovations | Jun 27, 1986 | SESE |
| K860366 | CHALLENGER HOT BIOPSY FORCEPS | Microvasive | Apr 7, 1986 | SESE |
| K853680 | ENDODYNAMIC SIEGEL SPHINCTEROTOME | E-Z-Em, Inc. | Nov 4, 1985 | SESE |
| K851958 | ROTATABLE POLYPECTOMY SNARE POS-1 | Wilson-Cook Medical, Inc. | Jul 25, 1985 | SESE |
| K851652 | PAPILLOTOME | Microvasive | Jun 24, 1985 | SESE |
| K851964 | E.R.C.P.-1 ENDOSCOPIC RETROGRADE CHOLANGIO-CATHETE | Wilson-Cook Medical, Inc. | Jun 13, 1985 | SESE |
| K851096 | HPU HEAT PROBE AUTOMATED ELECTROCAUTERY SYSTEM | Olympus Corp. | May 22, 1985 | SESE |
| K845015 | DAVOL PAPILLITOME | C.R. Bard, Inc. | Jan 15, 1985 | SESE |
| K842810 | INFRARED COAGULATOR | Endo Lase, Inc. | Oct 18, 1984 | SESE |
| K820430 | DIATHERMIC SNARES | American Endoscopy, Inc. | Apr 8, 1982 | SESE |
| K820240 | PAPILLOTOMES | American Endoscopy, Inc. | Mar 26, 1982 | SESE |
| K820405 | GROUND AID CAPHESIVE | Promedicon, Inc. | Mar 2, 1982 | SESE |
| K820196 | ELECTROSURGICAL DISP. DISPERSIVE PAD | Promedicon, Inc. | Feb 12, 1982 | SESE |
| K813434 | ELECTROSURGICAL DISP. DISPERSIVE PAD | Promedicon, Inc. | Jan 12, 1982 | SESE |
| K812213 | AUTOMATED ELECTROCAUTERY SYSTEM | University of Washington | Nov 5, 1981 | SESE |
| K810336 | POLYPECTOMY SNARE | Medi-Tech, Inc. | Mar 20, 1981 | SESE |
| K802444 | PAPILLOTOME PRODUCT | Mill-Rose Laboratory | Oct 23, 1980 | SESE |
| K800915 | JOHNLOZ ENDOSCOPY HANDLE | Endoscopic Surgical Accessories, Inc. | May 30, 1980 | SESE |
| K800975 | M.R. ASSOC. TRUE-FEEL HANDLE | Mr Associates, Inc. | May 8, 1980 | SESE |
| K800974 | M.R. ASSOC. POWER CORD | Mr Associates, Inc. | May 8, 1980 | SESE |
| K800973 | M.R. ASSOC. HOT BIOPSY FORCEPS | Mr Associates, Inc. | May 8, 1980 | SESE |
| K800965 | M.R. ASSOC. SNARES; CRESCENT SNARE WIRE | Mr Associates, Inc. | May 8, 1980 | SESE |
| K800964 | M.R. ASSOC. BALL TYPE COAGULATOR | Mr Associates, Inc. | May 8, 1980 | SESE |
| K800321 | CONCEPT SUCTION COAGULATOR | Concept, Inc. | Feb 28, 1980 | SESE |
| K781353 | PAPILLOTOME CUTTING SNARE | Cameron-Miller, Inc. | Oct 10, 1978 | SESE |
| K780774 | PAPILLOTOMY KNIVES | Olympus Corp. | Jul 27, 1978 | SESE |
| K770280 | CORD, ELECTROSURGICAL-STERILE & DISPOS. | V. Mueller O.V. Baxter Healthcare Corp. | Apr 15, 1977 | SESE |
| K760178 | ELECTRODE, CUTTING LOOP | V. Mueller O.V. Baxter Healthcare Corp. | Oct 15, 1976 | SESE |
Top Applicants
- Wilson-Cook Medical, Inc. — 11 clearances
- Boston Scientific Corp — 9 clearances
- Olympus Medical Systems Corp. — 7 clearances
- Boston Scientific Corporation — 7 clearances
- Mr Associates, Inc. — 5 clearances
