Cleared Special

K140763 - MONOFILAMENT POLYPECTOMY SNARE (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K140763 · United States Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
28d
Days
Class 2
Risk

K140763 is an FDA 510(k) clearance for the MONOFILAMENT POLYPECTOMY SNARE. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by United States Endoscopy (Mentor, US). The FDA issued a Cleared decision on April 24, 2014 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all United States Endoscopy devices

Submission Details

510(k) Number K140763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2014
Decision Date April 24, 2014
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FDI Snare, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDI Snare, Flexible

All 62
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K140763.
Advanced Tissue Resection Device
K251692 · Micro-Tech (Nanjing) Co., Ltd. · Feb 2026
Polypectomy Snare
K221713 · Hangzhou AGS MedTech Co., Ltd. · Mar 2023
CORE-SNARE
K220846 · Incore Co., Ltd. · Nov 2022
Disposable Polyp Snare
K220089 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Sep 2022
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
K220790 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Jun 2022
Disposable Polypectomy Snare
K213222 · Beijing Zksk Technology Co., Ltd. · Jun 2022