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Irrigation/Aspiration Polypectomy Snare

by United States Endoscopy Group, Inc.

510(k) K970356

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970356 Date25 Mar 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Irrigation/Aspiration Polypectomy
510(k) Number
FDA Product Code
FDI
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Flexible Snare (per FDA nomenclature) designed for polypectomy during flexible endoscopy. It combines electrocautery excision with integrated irrigation and aspiration to remove polyps from the gastrointestinal or urinary tract. The snare wire is deployed around the polyp, closed under electrocautery, and simultaneously irrigated and aspirated to clear debris during the procedure.

The device is supplied sterile for single-use in clinical settings, including gastroenterology and urology. It is classified as a Class II medical device under 21 CFR 876.4300 and cleared via the Traditional 510(k) pathway (K970356). No MRI safety or reusable specifications are noted in the regulatory data. Storage and handling must comply with sterile instrument protocols.

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