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).
Recent Cleared Devices (20 of 63)
Showing 20 most recent of 63 cleared devices.
| 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 |
Top Applicants
- United States Endoscopy Group, Inc. — 10 clearances
- Boston Scientific Corp — 5 clearances
- Boston Scientific Corporation — 3 clearances
- Horizons Intl. Corp. — 3 clearances
- Cox Medical Ent., Inc. — 2 clearances
