Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

KNS 2026-05-21

Sphincterotome

Applicant Taewoong Medical Co., Ltd.

K number K260962

KNS 2025-11-26

Vanquish Water Vapor Ablation Device

Applicant Francis Medical, Inc.

K number K252388

KNS 2025-11-25

Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)

Applicant Olympus Medical Systems Corporation

K number K252889

KNS 2025-10-17

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)

K number K250945

KNS 2025-10-10

Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)

Applicant Olympus Medical Systems Corporation

K number K250351

KNS 2025-09-29

SureTome™ SW Sphincterotome with DomeTip

Applicant Wilson-Cook Medical

K number K251104

KNS 2025-08-08

Aqua Medical RF Vapor Ablation System

Applicant Aqua Medical, Inc.

K number K251226

KNS 2025-06-11

Rezum System

K number K250584

KNS 2025-06-06

SpydrBlade Flex Instrument (PRD-RG1-001)

Applicant Creo Medical, Ltd.

K number K242774

KNS 2025-03-26

SB Knife Jr2 (MD-47702 and MD-47702L)

Applicant Sb-Kawasumi Laboratories, Inc.

K number K241855

KNS 2025-02-06

Disposable Sphincterotome

Applicant Beijing Zksk Technology Co., Ltd.

K number K242192

KNS 2025-01-17

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord

K number K243568

KNS 2024-12-12

Aqua Medical RF Vapor Ablation System

Applicant Aqua Medical, Inc.

K number K241271

KNS 2024-08-15

Reusable Interface Cable 1.5 m (PRD-IFC-002)

Applicant Creo Medical, Ltd.

K number K242061

KNS 2024-03-29

Disposable Sphincterotome

Applicant Jiangsu Vedkang Medical Science and Technology Co., Ltd.

K number K232825

KNS 2023-11-28

Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter

Applicant Boston Scientific

K number K232633

KNS 2023-11-07

Disposable Sphincterotome

Applicant Zhejiang Soudon Medical Technology Co., Ltd.

K number K232476

KNS 2023-10-31

Speedboat Flush SB1 Instrument

Applicant Creo Medical, Ltd.

K number K230328

KNS 2023-10-27

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)

K number K233318

KNS 2023-10-25

ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)

Applicant Starmed Co., Ltd.

K number K233113

KNS 2023-08-14

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

K number K232162

KNS 2023-06-21

Habib EndoHPB

K number K231533

KNS 2023-05-03

Sphincterotome

Applicant Hangzhou AGS MedTech Co., Ltd.

K number K222421

KNS 2023-04-05

Optimos™ Cystotome

Applicant Taewoong Medical Co., Ltd.

K number K223256

KNS 2022-09-21

MCB UNIT Model: V10GMCBUS

Applicant Lamidey Noury Medical

K number K222542

KNS 2022-06-09

Cysto-Gastro-Sets

Applicant G-Flex Europe Sprl

K number K211909

KNS 2022-03-21

Multi-Functional Electrosurgical Knife

Applicant Anrei Medical (Hangzhou) Co., Ltd.

K number K212999

KNS 2021-12-17

RF Vapor System

Applicant Aqua Medical, Inc.

K number K213627

KNS 2021-12-01

Sphincterotome / short-wire compatible, Sterile Sphincterotome

Applicant Micro-Tech (Nanjing) Co., Ltd.

K number K210934

KNS 2021-05-27

Aqua Medical RF Vapor System

Applicant Aqua Medical, Inc.

K number K211282

KNS 2021-02-05

Sphincterotome

Applicant Hangzhou AGS MedTech Co., Ltd.

K number K201121

KNS 2020-12-03

ORISE ProKnife

K number K200404

KNS 2020-05-21

Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)

Applicant Hangzhou AGS MedTech Co., Ltd.

K number K192342

KNS 2020-03-19

Creo Electrosurgical System with HS1 Hemostasis Accessory

Applicant Creo Medical, Ltd.

K number K192905

KNS 2020-01-30

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord

K number K192339

KNS 2019-12-17

Single Use Balloon Dilator V (with knife)

K number K193039

KNS 2019-08-02

Rezum System

Applicant Nxthera (A Boston Scientific Company)

K number K191505

KNS 2019-06-21

Aqua Medical RF Vapor System

Applicant Aqua Medical, Inc.

K number K183595

KNS 2019-05-15

Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645

K number K182408

KNS 2019-04-23

SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long

Applicant Sumitomo Bakelite Co., Ltd.

K number K190621

KNS 2019-04-11

ELRA Electrode

Applicant Starmed Co., Ltd.

K number K181758

KNS 2019-03-25

Rezum Delivery Device, Rezum Generator

Applicant Nxthera (A Boston Scientific Company)

K number K190093

KNS 2018-05-24

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

Applicant Wilson-Cook Medical Inc./Cook Endoscopy

K number K172665

KNS 2018-04-17

Fusion OMNI Sphincterotome

Applicant Wilson-Cook Medical Inc./Cook Endoscopy

K number K172288

KNS 2018-03-20

Habib EndoHPB

Applicant Emcision , Ltd.

K number K180165

KNS 2018-02-27

Rezum System

Applicant Nxthera, Inc.

K number K180237

KNS 2018-01-18

Barrx SB RFA Endoscopic Catheter

Applicant Covidien, LLC

K number K173559

KNS 2017-11-17

Single Use Electrosurgical knife

K number K171158

KNS 2017-08-17

Zimmon Needle Knife Papillotome

Applicant Wilson-Cook Medical Inc./Cook Endoscopy

K number K171993

KNS 2017-08-17

Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory

Applicant Creo Medical, Ltd.

K number K171983

KNS 2016-06-17

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long

Applicant Sumitomo Bakelite Co., Ltd.

K number K152771

KNS 2016-03-17

Rezum System

Applicant Nxthera, Inc.

K number K160417

KNS 2016-03-02

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215

K number K160241

KNS 2013-07-26

BARRX CHANNEL RFA ENDOSCOPIC CATHETER

Applicant Covidien, LLC

K number K130623

KNS 2013-04-11

SINGLE USE PRELOADED SPHINCTEROTOME V

K number K122505

KNS 2012-12-14

GYRUS ACMI BICOAG HEMOSTASIS PROBE

Applicant Olympus Surgical Technologies America

K number K123319

KNS 2012-08-17

TRUETOME

Applicant Boston Scientific Corp

K number K122203

KNS 2011-04-14

INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER

K number K110887

KNS 2010-10-20

GYRUS ACMI BIOCOAG PROBE

Applicant Gyrus Acmi, Inc.

K number K092571

KNS 2010-09-07

MERIT BIPOLAR COAGULATION PROBE

Applicant Merit Medical Systems, Inc.

K number K102273

KNS 2010-08-02

TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U

Applicant Hobbs Medical, Inc.

K number K093079

KNS 2010-05-21

PROSTIVA RF THERAPY MODEL 8929 HAND PIECE

Applicant Medtronic, Inc.

K number K101139

KNS 2009-10-30

SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L

Applicant Olympus Medical Systems Corporation

K number K092309

KNS 2009-06-10

HABIB ENDOHPB

Applicant Emcision , Ltd.

K number K083292

KNS 2009-06-09

PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2

Applicant Max Endoscopy, Inc.

K number K083275

KNS 2008-12-19

ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00

Applicant Apollo Endosurgery, Inc.

K number K082114

KNS 2008-10-27

PROSTIVA RF THERAPY HAND PIECE, MODEL 8929

Applicant Medtronic, Inc.

K number K082464

KNS 2008-05-20

CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX

Applicant Conmed Endoscopic Technologies, Inc.

K number K080946

KNS 2007-11-29

HABIB ENDOBLATE

Applicant Emcision , Ltd.

K number K072383

KNS 2006-06-27

MEDI-GLOBE ROTA-CUT SPHINCTEROTOME

Applicant Medi-Globe Corporation

K number K061684

KNS 2005-11-17

TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934

Applicant Medtronic Vascular

K number K052413

KNS 2005-08-05

OMNI SPHINCTEROTOME

K number K052051

KNS 2005-04-22

COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE

Applicant Cook Ireland, Ltd.

K number K050578

KNS 2004-08-09

STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM

Applicant Stryker Endoscopy

K number K033135

KNS 2004-05-07

USW NEEDLEKNIFE PAPILLOTOME

K number K040981

KNS 2003-12-19

WILSON-COOK TRI-TOME SELECT PLUS

K number K033203

KNS 2003-06-27

ETI BIPOLAR HEMOSTATIC PROBE

Applicant Endo-Therapeutics, Inc.

K number K031026

KNS 2003-03-24

XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT

Applicant The Olympus Optical Co.

K number K030194

KNS 2003-02-27

MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM

Applicant Ultroid, LLC

K number K030315

KNS 2003-01-14

ULTROID HEMORRHOID MANAGEMENT SYSTEM

Applicant Ultroid, LLC

K number K023706

KNS 2002-10-17

WILSON-COOK CYSTOTOME

K number K022595

KNS 2002-09-27

ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018

Applicant Ethicon Endo-Surgery, Inc.

K number K021266

KNS 2001-12-11

RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE

Applicant Vidamed, Inc.

K number K012587

KNS 2001-10-19

AUTOTOME RX MODEL # 4515, 4516

Applicant Boston Scientific Corp

K number K013153

KNS 2001-07-06

PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE

Applicant Vidamed, Inc.

K number K011787

KNS 2001-03-27

ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM

Applicant Arthrocare Corp.

K number K010568

KNS 2001-02-13

TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM

Applicant Vidamed, Inc.

K number K002583

KNS 2001-01-23

HORIZONS PAPILLOTOME

Applicant Horizons Intl. Corp.

K number K002236

KNS 2000-12-19

PLASMAKINETIC ENDOUROLOGY SYSTEM

Applicant Gyrus Medical , Ltd.

K number K003569

KNS 2000-10-05

RAPID EXCHANGE TAPERTOME

Applicant Boston Scientific Corp

K number K002802

KNS 2000-04-18

THERMOFLEX SYSTEM

Applicant Argomed, Inc.

K number K000508

KNS 1999-12-27

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE

Applicant Gyrus Medical , Ltd.

K number K994166

KNS 1999-12-22

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

Applicant Telemed Systems, Inc.

K number K992402

KNS 1999-08-26

THERMOFLEX SYSTEM

Applicant Argomed, Inc.

K number K991847

KNS 1999-06-29

GYRUS ENDOUROLOGY SYSTEM

Applicant Gyrus Medical , Ltd.

K number K990628

KNS 1999-06-11

COOPERSURGICAL INFRARED COAGULATOR

Applicant CooperSurgical, Inc.

K number K990852

KNS 1999-06-01

COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL

Applicant CooperSurgical, Inc.

K number K990850

KNS 1999-05-03

BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME

Applicant Ballard Medical Products

K number K990376

KNS 1999-03-30

COOPERSURGICAL INFRARED COAGULATOR FOR ENT

Applicant CooperSurgical, Inc.

K number K990855