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Resuable Hot Biopsy Forceps

by United States Endoscopy Group, Inc.

510(k) K972505

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972505 Date18 Sep 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KGE
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Reusable Hot Biopsy Forceps is an Electric Biopsy Forceps designed for use in flexible endoscopy procedures. It is used to grasp, dissect, and transect gastrointestinal tissue, including lesions or polyps, while applying a monopolar electric current to ablate tissue from the intestinal wall.

This reusable device is intended for clinical use in gastroenterology and urology settings. It is not sterile upon receipt and must be sterilized before use. The forceps feature interchangeable jaws with varying diameters for different procedural needs. Authorized under FDA 510(k) clearance (K972505), it falls under Class II regulatory classification (876.4300) and is intended for single-patient use before reprocessing.

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