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FDI

63 FDA 510(k) clearances · Product code

90 daysmedian time to decision
255 days90th percentile
63clearances measured

FDA profile

Official device name
Snare, Flexible
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4300
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 211 · 2022: 246 · 2023: 209 · 2024: 279 · 2025: 277 · 2026: 214
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Advanced Tissue Resection Device (K251692)Micro-Tech (Nanjing) Co., Ltd.2026-02-21
Polypectomy Snare (K221713)Hangzhou AGS MedTech Co., Ltd.2023-03-03
CORE-SNARE (K220846)Incore Co., Ltd.2022-11-21
Disposable Polyp Snare (K220089)Jiangsu Vedkang Medical Science and Technology Co., Ltd.2022-09-22
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare (K220790)Yangzhou Fartley Medical Instrument Technology Co., Ltd.2022-06-27
Disposable Polypectomy Snare (K213222)Beijing Zksk Technology Co., Ltd.2022-06-06
SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) (K212860)STERIS Corporation2021-10-07
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares (K202478)Boston Scientific Corporation2020-10-08
Lariat, Hot/Cold Snare (K200745)United States Endoscopy Group, Inc.2020-04-21
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (K190512)Intelligent Endoscopy2019-11-22
AcuSnare Polypectomy Snare - Duckbill (K191048)Wilson-Cook Medical, Inc.2019-07-18
ClearGrasp Snare (K183289)Finemedix Co., Ltd.2019-03-06
Roth Net Retriever Product Line (K182909)United States Endoscopy Group, Inc.2018-11-21
AcuSnare Polypectomy Snare (K173673)Wilson-Cook Medical, Inc.2018-08-24
Polypectomy Snare (K172729)Hangzhou AGS MedTech Co., Ltd.2018-05-21
Rotatable Snares, Non-Rotatable Snares (K172758)Zhejiang Chuangxiang Medical Technology Co., Ltd.2018-03-07
Single Use Electrosurgical Snare SD-400 (K172734)Olympus Medical Systems Corp.2017-12-07
Rotatable Snares (K160637)Boston Scientific Corporation2016-03-30
rescuenet (K152580)Endochoice, Inc.2015-11-03
Polypectomy Snare (K150316)Micro-Tech (Nanjing) Co., Ltd.2015-07-30
Lariat snare (K151197)United States Endoscopy Group, Inc.2015-07-06
TRACTION POLYPECTOMY SNARE (K140923)Ovesco Endoscopy AG2014-11-18
PolyCatch Retrieval Device (K142258)Medi-Globe Corporation2014-09-30
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV (K140726)Boston Scientific Corp2014-07-21
MONOFILAMENT POLYPECTOMY SNARE (K140763)United States Endoscopy2014-04-24
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES (K133987)Boston Scientific Corporation2014-01-24
MULTI-STAGE SNARE (K133513)United States Endoscopy Group, Inc.2013-12-20
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES (K131700)Boston Scientific Corp2013-11-04
EC SINGLE USE, POLYPECTOMY SNARE (K123223)Endochoice, Inc.2013-01-10
ROTH NET RETRIEVER (K122462)United States Endoscopy Group, Inc.2012-09-11
UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION (K103611)United States Endoscopy Group, Inc.2011-05-09
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 (K091355)Conmed Endoscopic Technologies, Inc.2009-07-22
TORNADO ROTATABEL SNARE AND POLYP CATCHER (K083049)Horizons Intl. Corp.2008-12-23
ETHICON ENDO SURGERY ARTICULATING SNARE (K073288)Ethicon Endo-Surgery, Inc.2008-06-12
COOK IRELAND SONNET POLYPECTOMY SNARE (K050294)Cook Ireland, Ltd.2005-03-31
INJECTOR NEEDLE/SNARE (K040961)United States Endoscopy Group, Inc.2004-07-08
HORIZONS REUSABLE POLYPECTOMY SNARES (K022268)Horizons Intl. Corp.2002-10-25
NAKAO SNARE II AND NAKAO SNARE III (K020891)Granit Medical Innovations2002-06-17
HORIZONS INTERNATIONAL POLYPECTOMY SNARES (K011667)Horizons Intl. Corp.2001-08-16
SNARE,FLEXIBLE (K002927)Odon Lifetechnology2000-12-10
ROTOSNARE (K992477)Inscope, LLC1999-08-24
MILL-ROSE DISPOSABLE POLYPECTOMY SNARE (K971275)Mill-Rose Laboratory1997-05-23
IRRIGATION/ASPIRATION POLYPECTOMY (K970356)United States Endoscopy Group, Inc.1997-03-25
SNARE (K960230)Lighthouse Medical, Inc.1996-07-31
OLYMPUS SD SERIES SNARES (K955650)Olympus America, Inc.1996-03-29
MILL-ROSE ROTATABLE POLYPECTOMY SNARE (K951600)Mill-Rose Laboratory1995-12-18
GIP/MEDI-GLOBE POLYPECTOMY SNARES (K943935)Medi-Globe Corp.1995-05-26
SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES (K950496)Boston Scientific Corp1995-03-30
PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES (K941750)Boston Scientific Corp1994-11-01
INJECT-SNARE (K942110)Endovations1994-10-13
AMERICAN CATHETER POLY-SNARE (K940335)Intl. Medical, Inc.1994-07-21
ENDOSNARE (K923031)Cook Urological, Inc.1993-06-07
SPHINCTEROTOME (K930022)Boston Scientific Corp1993-04-27
SNARE FLEXIBLE (K924105)United States Endoscopy Group, Inc.1992-11-24
COX DISPOSABLE POLYPECTOMY SNARES (K923671)Cox Medical Ent., Inc.1992-10-13
COX DIAPOSABLE POLYPECTOMY SNARE (K912254)Cox Medical Ent., Inc.1991-07-26
LAPAROSCOPIC SNARE (K911482)United States Endoscopy Group, Inc.1991-04-22
FLEXIBLE SNARE (K902265)Annex Medical, Inc.1990-07-27
DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE (K901428)Telemed Systems, Inc.1990-06-18
DOBBHOFF(R) POLYPECTOMY SNARE (K901322)Biosearch Medical Products, Inc.1990-06-15
WILTEK POLYPECTOMY SNARE (K894869)Wiltek Medical, Inc.1989-12-21
BIPOLAR ELECTROSURGICAL SNARE (K893553)Everest Medical Corp.1989-09-08
DAVOL POLYPECTOMY SNARE (K845016)C.R. Bard, Inc.1985-01-15

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