Product code KNS— Gastroenterology, Urology
Rezum System
- Classification name
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 189
- First cleared
- Most recent
Market context for product code KNS
FDA has cleared devices under product code KNS between 1976 and 2026, filed by 92 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code KNS
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 189- K262460 — Rezum System
- 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) +3 more
- K250351 — Single Use Electrosurgical Knife (3 models)
- 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 (6 models)
- 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 +6 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.