FDI · Class II · 21 CFR 876.4300

FDA Product Code FDI: Snare, Flexible

Leading manufacturers include Boston Scientific Corp, Boston Scientific Corporation and Hangzhou AGS MedTech Co., Ltd..

63
Total
63
Cleared
121d
Avg days
1985
Since
Declining activity - 1 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 264d recently vs 119d historically

FDA 510(k) Cleared Snare, Flexible Devices (Product Code FDI)

63 devices
1–24 of 63
Cleared Feb 21, 2026
Advanced Tissue Resection Device
K251692
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 264d
Cleared Mar 03, 2023
Polypectomy Snare
K221713
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 263d
Cleared Nov 21, 2022
CORE-SNARE
K220846
Incore Co., Ltd.
Gastroenterology & Urology · 243d
Cleared Sep 22, 2022
Disposable Polyp Snare
K220089
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Gastroenterology & Urology · 254d
Cleared Jun 27, 2022
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
K220790
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Gastroenterology & Urology · 102d
Cleared Jun 06, 2022
Disposable Polypectomy Snare
K213222
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 250d
Cleared Oct 07, 2021
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 Corporation
Gastroenterology & Urology · 29d
Cleared Oct 08, 2020
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
K202478
Boston Scientific Corporation
Gastroenterology & Urology · 41d
Cleared Apr 21, 2020
Lariat, Hot/Cold Snare
K200745
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 29d
Cleared Nov 22, 2019
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
K190512
Intelligent Endoscopy
Gastroenterology & Urology · 266d
Cleared Jul 18, 2019
AcuSnare Polypectomy Snare - Duckbill
K191048
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 06, 2019
ClearGrasp Snare
K183289
Finemedix Co., Ltd.
Gastroenterology & Urology · 100d
Cleared Nov 21, 2018
Roth Net Retriever Product Line
K182909
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 35d
Cleared Aug 24, 2018
AcuSnare Polypectomy Snare
K173673
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 267d
Cleared May 21, 2018
Polypectomy Snare
K172729
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 252d
Cleared Mar 07, 2018
Rotatable Snares, Non-Rotatable Snares
K172758
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Gastroenterology & Urology · 175d
Cleared Dec 07, 2017
Single Use Electrosurgical Snare SD-400
K172734
Olympus Medical Systems Corp.
Gastroenterology & Urology · 87d
Cleared Mar 30, 2016
Rotatable Snares
K160637
Boston Scientific Corporation
Gastroenterology & Urology · 23d
Cleared Jul 21, 2014
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV
K140726
Boston Scientific Corp
Gastroenterology & Urology · 119d
Cleared Jan 24, 2014
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
K133987
Boston Scientific Corporation
Gastroenterology & Urology · 29d
Cleared Nov 04, 2013
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES
K131700
Boston Scientific Corp
Gastroenterology & Urology · 146d
Cleared Mar 30, 1995
SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
K950496
Boston Scientific Corp
Gastroenterology & Urology · 52d
Cleared Nov 01, 1994
PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES
K941750
Boston Scientific Corp
Gastroenterology & Urology · 207d
Cleared Apr 27, 1993
SPHINCTEROTOME
K930022
Boston Scientific Corp
Gastroenterology & Urology · 112d

About Product Code FDI - Regulatory Context

510(k) Submission Activity

63 total 510(k) submissions under product code FDI since 1985, with 63 receiving FDA clearance (average review time: 121 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - FDI Product Code

Recent submissions under FDI have taken an average of 264 days to reach a decision - up from 119 days historically. Manufacturers should account for longer review timelines in current project planning.

FDI devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →