Product code KNS— Gastroenterology, Urology
Rezum System
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 188
Adverse events under product code KNS
product code KNS- Death
- 44
- Injury
- 2,361
- Malfunction
- 4,771
- Total
- 7,176
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KNS
1–100 of 188- K260962 — Sphincterotome
- K252388 — Vanquish Water Vapor Ablation Device
- K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
- 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)
- K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
- K251104 — SureTome SW Sphincterotome with DomeTip
- K251226 — Aqua Medical RF Vapor Ablation System
- K250584 — Rezum System
- K242774 — SpydrBlade Flex Instrument (PRD-RG1-001)
- K241855 — SB Knife Jr2 (MD-47702 and MD-47702L)
- K242192 — Disposable Sphincterotome
- K243568 — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
- K241271 — Aqua Medical RF Vapor Ablation System
- K242061 — Reusable Interface Cable 1.5 m (PRD-IFC-002)
- K232825 — Disposable Sphincterotome
- K232633 — Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter
- K232476 — Disposable Sphincterotome
- K230328 — Speedboat Flush SB1 Instrument
- 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)
- K233113 — ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)
- 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
- K231533 — Habib EndoHPB
- K222421 — Sphincterotome
- K223256 — Optimos Cystotome
- K222542 — MCB UNIT Model: V10GMCBUS
- K211909 — Cysto-Gastro-Sets
- K212999 — Multi-Functional Electrosurgical Knife
- K213627 — RF Vapor System
- K210934 — Sphincterotome / short-wire compatible, Sterile Sphincterotome
- K211282 — Aqua Medical RF Vapor System
- K201121 — Sphincterotome
- K200404 — ORISE ProKnife
- K192342 — Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
- K192905 — Creo Electrosurgical System with HS1 Hemostasis Accessory
- K192339 — TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
- K193039 — Single Use Balloon Dilator V (with knife)
- K191505 — Rezum System
- K183595 — Aqua Medical RF Vapor System
- K182408 — Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
- K190621 — SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
- K181758 — ELRA Electrode
- K190093 — Rezum Delivery Device, Rezum Generator
- 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
- K172288 — Fusion OMNI Sphincterotome
- K180165 — Habib EndoHPB
- K180237 — Rezum System
- K173559 — Barrx SB RFA Endoscopic Catheter
- K171158 — Single Use Electrosurgical knife
- K171983 — Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory
- K171993 — Zimmon Needle Knife Papillotome
- K152771 — SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long
- K160417 — Rezum System
- K160241 — Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
- K150142 — Single Use Balloon Dilator V (with Knife)
- K150786 — Rezum System
- K141991 — SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP
- K133933 — INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
- K130623 — BARRX CHANNEL RFA ENDOSCOPIC CATHETER
- K122505 — SINGLE USE PRELOADED SPHINCTEROTOME V
- K123319 — GYRUS ACMI BICOAG HEMOSTASIS PROBE
- K122203 — TRUETOME
- K110887 — INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
- K092571 — GYRUS ACMI BIOCOAG PROBE
- K102273 — MERIT BIPOLAR COAGULATION PROBE
- K093079 — TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U
- K101139 — PROSTIVA RF THERAPY MODEL 8929 HAND PIECE
- K092309 — SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L
- K083292 — HABIB ENDOHPB
- K083275 — PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
- K082114 — ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00
- K082464 — PROSTIVA RF THERAPY HAND PIECE, MODEL 8929
- K080946 — CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
- K072383 — HABIB ENDOBLATE
- K061684 — MEDI-GLOBE ROTA-CUT SPHINCTEROTOME
- K052413 — TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
- K052051 — OMNI SPHINCTEROTOME
- K050578 — COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
- K033135 — STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM
- K040981 — USW NEEDLEKNIFE PAPILLOTOME
- K033203 — WILSON-COOK TRI-TOME SELECT PLUS
- K031026 — ETI BIPOLAR HEMOSTATIC PROBE
- K030194 — XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
- K030315 — MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
- K023706 — ULTROID HEMORRHOID MANAGEMENT SYSTEM
- K022595 — WILSON-COOK CYSTOTOME
- K021266 — ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
- K012587 — RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE
- K013153 — AUTOTOME RX MODEL # 4515, 4516
- K011787 — PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE
- K010568 — ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
- K002583 — TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM
- K002236 — HORIZONS PAPILLOTOME
- K003569 — PLASMAKINETIC ENDOUROLOGY SYSTEM
- K002802 — RAPID EXCHANGE TAPERTOME
- K000508 — THERMOFLEX SYSTEM
- K994166 — GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
- 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
- K991847 — THERMOFLEX SYSTEM
- K990628 — GYRUS ENDOUROLOGY SYSTEM
- K990852 — COOPERSURGICAL INFRARED COAGULATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.