FDI · Snare, Flexible
Gastroenterology, Urology · 21 CFR 876.4300 · Class 2
Overview
| Product Code | FDI |
|---|---|
| Device Name | Snare, Flexible |
| 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 (63)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251692 | Advanced Tissue Resection Device | Micro-Tech (Nanjing) Co., Ltd. | Feb 21, 2026 | SESE |
| K221713 | Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. | Mar 3, 2023 | SESE |
| K220846 | CORE-SNARE | Incore Co., Ltd. | Nov 21, 2022 | SESE |
| K220089 | Disposable Polyp Snare | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Sep 22, 2022 | SESE |
| K220790 | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Jun 27, 2022 | SESE |
| K213222 | Disposable Polypectomy Snare | Beijing Zksk Technology Co., Ltd. | Jun 6, 2022 | SESE |
| K212860 | 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) | STERIS Corporation | Oct 7, 2021 | SESE |
| K202478 | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares | Boston Scientific Corporation | Oct 8, 2020 | SESE |
| K200745 | Lariat, Hot/Cold Snare | United States Endoscopy Group, Inc. | Apr 21, 2020 | SESE |
| K190512 | SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare | Intelligent Endoscopy | Nov 22, 2019 | SESE |
| K191048 | AcuSnare Polypectomy Snare - Duckbill | Wilson-Cook Medical, Inc. | Jul 18, 2019 | SESE |
| K183289 | ClearGrasp Snare | Finemedix Co., Ltd. | Mar 6, 2019 | SESE |
| K182909 | Roth Net Retriever Product Line | United States Endoscopy Group, Inc. | Nov 21, 2018 | SESE |
| K173673 | AcuSnare Polypectomy Snare | Wilson-Cook Medical, Inc. | Aug 24, 2018 | SESE |
| K172729 | Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. | May 21, 2018 | SESE |
| K172758 | Rotatable Snares, Non-Rotatable Snares | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Mar 7, 2018 | SESE |
| K172734 | Single Use Electrosurgical Snare SD-400 | Olympus Medical Systems Corp. | Dec 7, 2017 | SESE |
| K160637 | Rotatable Snares | Boston Scientific Corporation | Mar 30, 2016 | SESE |
| K152580 | rescuenet | Endochoice, Inc. | Nov 3, 2015 | SESE |
| K150316 | Polypectomy Snare | Micro-Tech (Nanjing) Co., Ltd. | Jul 30, 2015 | SESE |
| K151197 | Lariat snare | United States Endoscopy Group, Inc. | Jul 6, 2015 | SESE |
| K140923 | TRACTION POLYPECTOMY SNARE | Ovesco Endoscopy AG | Nov 18, 2014 | SESE |
| K142258 | PolyCatch Retrieval Device | Medi-Globe Corporation | Sep 30, 2014 | SESE |
| K140726 | CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV | Boston Scientific Corp | Jul 21, 2014 | SESE |
| K140763 | MONOFILAMENT POLYPECTOMY SNARE | United States Endoscopy | Apr 24, 2014 | SESE |
| K133987 | CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES | Boston Scientific Corporation | Jan 24, 2014 | SESE |
| K133513 | MULTI-STAGE SNARE | United States Endoscopy Group, Inc. | Dec 20, 2013 | SESE |
| K131700 | SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES | Boston Scientific Corp | Nov 4, 2013 | SESE |
| K123223 | EC SINGLE USE, POLYPECTOMY SNARE | Endochoice, Inc. | Jan 10, 2013 | SESE |
| K122462 | ROTH NET RETRIEVER | United States Endoscopy Group, Inc. | Sep 11, 2012 | SESE |
| K103611 | UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION | United States Endoscopy Group, Inc. | May 9, 2011 | SESE |
| K091355 | DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 | Conmed Endoscopic Technologies, Inc. | Jul 22, 2009 | SESE |
| K083049 | TORNADO ROTATABEL SNARE AND POLYP CATCHER | Horizons Intl. Corp. | Dec 23, 2008 | SESE |
| K073288 | ETHICON ENDO SURGERY ARTICULATING SNARE | Ethicon Endo-Surgery, Inc. | Jun 12, 2008 | SESE |
| K050294 | COOK IRELAND SONNET POLYPECTOMY SNARE | Cook Ireland, Ltd. | Mar 31, 2005 | SESE |
| K040961 | INJECTOR NEEDLE/SNARE | United States Endoscopy Group, Inc. | Jul 8, 2004 | SESE |
| K022268 | HORIZONS REUSABLE POLYPECTOMY SNARES | Horizons Intl. Corp. | Oct 25, 2002 | SESE |
| K020891 | NAKAO SNARE II AND NAKAO SNARE III | Granit Medical Innovations | Jun 17, 2002 | SESE |
| K011667 | HORIZONS INTERNATIONAL POLYPECTOMY SNARES | Horizons Intl. Corp. | Aug 16, 2001 | SESE |
| K002927 | SNARE,FLEXIBLE | Odon Lifetechnology | Dec 10, 2000 | SESE |
| K992477 | ROTOSNARE | Inscope, LLC | Aug 24, 1999 | SESE |
| K971275 | MILL-ROSE DISPOSABLE POLYPECTOMY SNARE | Mill-Rose Laboratory | May 23, 1997 | SESE |
| K970356 | IRRIGATION/ASPIRATION POLYPECTOMY | United States Endoscopy Group, Inc. | Mar 25, 1997 | SESE |
| K960230 | SNARE | Lighthouse Medical, Inc. | Jul 31, 1996 | SESE |
| K955650 | OLYMPUS SD SERIES SNARES | Olympus America, Inc. | Mar 29, 1996 | SESE |
| K951600 | MILL-ROSE ROTATABLE POLYPECTOMY SNARE | Mill-Rose Laboratory | Dec 18, 1995 | SESE |
| K943935 | GIP/MEDI-GLOBE POLYPECTOMY SNARES | Medi-Globe Corp. | May 26, 1995 | SESE |
| K950496 | SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES | Boston Scientific Corp | Mar 30, 1995 | SESE |
| K941750 | PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES | Boston Scientific Corp | Nov 1, 1994 | SESE |
| K942110 | INJECT-SNARE | Endovations | Oct 13, 1994 | SESE |
| K940335 | AMERICAN CATHETER POLY-SNARE | Intl. Medical, Inc. | Jul 21, 1994 | SESE |
| K923031 | ENDOSNARE | Cook Urological, Inc. | Jun 7, 1993 | SESE |
| K930022 | SPHINCTEROTOME | Boston Scientific Corp | Apr 27, 1993 | SESE |
| K924105 | SNARE FLEXIBLE | United States Endoscopy Group, Inc. | Nov 24, 1992 | SESE |
| K923671 | COX DISPOSABLE POLYPECTOMY SNARES | Cox Medical Ent., Inc. | Oct 13, 1992 | SESE |
| K912254 | COX DIAPOSABLE POLYPECTOMY SNARE | Cox Medical Ent., Inc. | Jul 26, 1991 | SESE |
| K911482 | LAPAROSCOPIC SNARE | United States Endoscopy Group, Inc. | Apr 22, 1991 | SESE |
| K902265 | FLEXIBLE SNARE | Annex Medical, Inc. | Jul 27, 1990 | SESE |
| K901428 | DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE | Telemed Systems, Inc. | Jun 18, 1990 | SESE |
| K901322 | DOBBHOFF(R) POLYPECTOMY SNARE | Biosearch Medical Products, Inc. | Jun 15, 1990 | SESE |
| K894869 | WILTEK POLYPECTOMY SNARE | Wiltek Medical, Inc. | Dec 21, 1989 | SESE |
| K893553 | BIPOLAR ELECTROSURGICAL SNARE | Everest Medical Corp. | Sep 8, 1989 | SESE |
| K845016 | DAVOL POLYPECTOMY SNARE | C.R. Bard, Inc. | Jan 15, 1985 | SESE |
Top Applicants
- United States Endoscopy Group, Inc. — 10 clearances
- Boston Scientific Corp — 5 clearances
- Horizons Intl. Corp. — 3 clearances
- Boston Scientific Corporation — 3 clearances
- Wilson-Cook Medical, Inc. — 2 clearances
