Product Code: FDI
FDA class 2
21 CFR 876.4300
Snare, Flexible
Gastroenterology, Urology
The Flexible Snare (product code FDI) is an electrosurgical accessory consisting of a flexible wire loop passed through an endoscope to encircle and resect polyps or other lesions in the gastrointestinal or urological tract. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.4300 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.
510(k)s
62
FEI Numbers
68
Registration Numbers
68
Unique Applicants
44
Years Active
38
Basic Information
- Product Code
- FDI
- Device Class
- FDA class 2
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 62 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K221713 | Polypectomy Snare | Mar 03, 2023 | Substantially Equivalent | Hangzhou AGS MedTech Co., Ltd. |
| K220846 | CORE-SNARE | Nov 21, 2022 | Substantially Equivalent | Incore Co., Ltd. |
| K220089 | Disposable Polyp Snare | Sep 22, 2022 | Substantially Equivalent | Jiangsu Vedkang Medical Science and Technology Co.,Ltd. |
| K220790 | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare | Jun 27, 2022 | Substantially Equivalent | Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
| K213222 | Disposable Polypectomy Snare | Jun 06, 2022 | Substantially Equivalent | Beijing ZKSK Technology Co.,Ltd |
| 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) | Oct 07, 2021 | Substantially Equivalent | Steris Corporation |
| K202478 | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares | Oct 08, 2020 | Substantially Equivalent | Boston Scientific Corporation |
| K200745 | Lariat, Hot/Cold Snare | Apr 21, 2020 | Substantially Equivalent | United States Endoscopy Group, Inc. |
| K190512 | SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare | Nov 22, 2019 | Substantially Equivalent | Intelligent Endoscopy |
| K191048 | AcuSnare Polypectomy Snare - Duckbill | Jul 18, 2019 | Substantially Equivalent | Wilson-Cook Medical, Inc. |
| K183289 | ClearGrasp Snare | Mar 06, 2019 | Substantially Equivalent | Finemedix Co., Ltd. |
| K182909 | Roth Net Retriever Product Line | Nov 21, 2018 | Substantially Equivalent | United States Endoscopy Group, Inc. |
| K173673 | AcuSnare Polypectomy Snare | Aug 24, 2018 | Substantially Equivalent | Wilson-Cook Medical, Inc |
| K172729 | Polypectomy Snare | May 21, 2018 | Substantially Equivalent | Hangzhou AGS MedTech CO., Ltd |
| K172758 | Rotatable Snares, Non-Rotatable Snares | Mar 07, 2018 | Substantially Equivalent | Zhejiang Chuangxiang Medical Technology Co., LTD. |
| K172734 | Single Use Electrosurgical Snare SD-400 | Dec 07, 2017 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K160637 | Rotatable Snares | Mar 30, 2016 | Substantially Equivalent | BOSTON SCIENTIFIC CORPORATION |
| K152580 | rescuenet | Nov 03, 2015 | Substantially Equivalent | ENDOCHOICE, INC. |
| K150316 | Polypectomy Snare | Jul 30, 2015 | Substantially Equivalent | MICRO- TECH (NANJING) CO., LTD. |
| K151197 | Lariat snare | Jul 06, 2015 | Substantially Equivalent | UNITED STATES ENDOSCOPY GROUP, INC. |
| K140923 | TRACTION POLYPECTOMY SNARE | Nov 18, 2014 | Substantially Equivalent | OVESCO ENDOSCOPY AG |
| K142258 | PolyCatch Retrieval Device | Sep 30, 2014 | Substantially Equivalent | Medi-Globe Corporation |
| K140726 | CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV | Jul 21, 2014 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K140763 | MONOFILAMENT POLYPECTOMY SNARE | Apr 24, 2014 | Substantially Equivalent | UNITED STATES ENDOSCOPY |
| K133987 | CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES | Jan 24, 2014 | Substantially Equivalent | Boston Scientific Corporation |
| K133513 | MULTI-STAGE SNARE | Dec 20, 2013 | Substantially Equivalent | UNITED STATES ENDOSCOPY GROUP, INC. |
| K131700 | SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES | Nov 04, 2013 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K123223 | EC SINGLE USE, POLYPECTOMY SNARE | Jan 10, 2013 | Substantially Equivalent | ENDOCHOICE, INC. |
| K122462 | ROTH NET RETRIEVER | Sep 11, 2012 | Substantially Equivalent | UNITED STATES ENDOSCOPY GROUP, INC. |
| K103611 | UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION | May 09, 2011 | Substantially Equivalent | UNITED STATES ENDOSCOPY GROUP, INC. |
| K091355 | DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 | Jul 22, 2009 | Substantially Equivalent | CONMED ENDOSCOPIC TECHNOLOGIES, INC. |
| K083049 | TORNADO ROTATABEL SNARE AND POLYP CATCHER | Dec 23, 2008 | Substantially Equivalent | HORIZONS INTL. CORP. |
| K073288 | ETHICON ENDO SURGERY ARTICULATING SNARE | Jun 12, 2008 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K050294 | COOK IRELAND SONNET POLYPECTOMY SNARE | Mar 31, 2005 | Substantially Equivalent | COOK IRELAND LTD |
| K040961 | INJECTOR NEEDLE/SNARE | Jul 08, 2004 | Substantially Equivalent | UNITED STATES ENDOSCOPY GROUP, INC. |
| K022268 | HORIZONS REUSABLE POLYPECTOMY SNARES | Oct 25, 2002 | Substantially Equivalent | HORIZONS INTL. CORP. |
| K020891 | NAKAO SNARE II AND NAKAO SNARE III | Jun 17, 2002 | Substantially Equivalent | GRANIT MEDICAL INNOVATIONS |
| K011667 | HORIZONS INTERNATIONAL POLYPECTOMY SNARES | Aug 16, 2001 | Substantially Equivalent | HORIZONS INTL. CORP. |
| K002927 | SNARE,FLEXIBLE | Dec 10, 2000 | Substantially Equivalent | ODON LIFETECHNOLOGY |
| K992477 | ROTOSNARE | Aug 24, 1999 | Substantially Equivalent | INSCOPE, LLC. |
| K971275 | MILL-ROSE DISPOSABLE POLYPECTOMY SNARE | May 23, 1997 | Substantially Equivalent | MILL-ROSE LABORATORY |
| K970356 | IRRIGATION/ASPIRATION POLYPECTOMY | Mar 25, 1997 | Substantially Equivalent | UNITED STATES ENDOSCOPY GROUP, INC. |
| K960230 | SNARE | Jul 31, 1996 | Substantially Equivalent | LIGHTHOUSE MEDICAL, INC. |
| K955650 | OLYMPUS SD SERIES SNARES | Mar 29, 1996 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K951600 | MILL-ROSE ROTATABLE POLYPECTOMY SNARE | Dec 18, 1995 | Substantially Equivalent | MILL-ROSE LABORATORY |
| K943935 | GIP/MEDI-GLOBE POLYPECTOMY SNARES | May 26, 1995 | Substantially Equivalent | MEDI-GLOBE CORP. |
| K950496 | SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES | Mar 30, 1995 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K941750 | PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES | Nov 01, 1994 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K942110 | INJECT-SNARE | Oct 13, 1994 | Substantially Equivalent | ENDOVATIONS |
| K940335 | AMERICAN CATHETER POLY-SNARE | Jul 21, 1994 | Substantially Equivalent | INTL. MEDICAL, INC. |
| K923031 | ENDOSNARE | Jun 07, 1993 | Substantially Equivalent | COOK UROLOGICAL, INC. |
| K930022 | SPHINCTEROTOME | Apr 27, 1993 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K924105 | SNARE FLEXIBLE | Nov 24, 1992 | Substantially Equivalent | UNITED STATES ENDOSCOPY GROUP, INC. |
| K923671 | COX DISPOSABLE POLYPECTOMY SNARES | Oct 13, 1992 | Substantially Equivalent | COX MEDICAL ENT., INC. |
| K912254 | COX DIAPOSABLE POLYPECTOMY SNARE | Jul 26, 1991 | Substantially Equivalent | COX MEDICAL ENT., INC. |
| K911482 | LAPAROSCOPIC SNARE | Apr 22, 1991 | Substantially Equivalent | UNITED STATES ENDOSCOPY GROUP, INC. |
| K902265 | FLEXIBLE SNARE | Jul 27, 1990 | Substantially Equivalent | ANNEX MEDICAL, INC. |
| K901428 | DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE | Jun 18, 1990 | Substantially Equivalent | TELEMED SYSTEMS, INC. |
| K901322 | DOBBHOFF(R) POLYPECTOMY SNARE | Jun 15, 1990 | Substantially Equivalent | BIOSEARCH MEDICAL PRODUCTS, INC. |
| K894869 | WILTEK POLYPECTOMY SNARE | Dec 21, 1989 | Substantially Equivalent | WILTEK MEDICAL, INC. |
| K893553 | BIPOLAR ELECTROSURGICAL SNARE | Sep 08, 1989 | Substantially Equivalent | EVEREST MEDICAL CORP. |
| K845016 | DAVOL POLYPECTOMY SNARE | Jan 15, 1985 | Substantially Equivalent | C.R. BARD, INC. |
FEI Numbers
This FDA classification entry is associated with 68 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 68 registration numbers. Click on an entry to view related FDA registrations.