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Avulsion Forceps

by Steris Corporation

510(k) K183428

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 NumberK183428 Date16 Apr 2019ClearedStatusActive

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  • Withdrawn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, 26 Sep 2026

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

Avulsion Forceps are a Class II endoscopic electrosurgical unit and accessory device used in gastroenterology and urology procedures. The device is substantially equivalent to a predicate and cleared via the traditional 510(k) pathway.

Manufactured by STERIS Corporation, the Avulsion Forceps (K183428) received FDA 510(k) clearance on April 16, 2019, under regulation number 876.4300 and product code KGE. The device is supplied non-sterile and intended for reusable use following appropriate reprocessing.

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Questions

AI-generated answers, 26 Sep 2026

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

  • What is the Avulsion Forceps used for?

    The Avulsion Forceps is an endoscopic electrosurgical unit and accessory device used in gastroenterology and urology procedures, designed for tissue manipulation and ablation during endoscopic interventions.

  • Is the Avulsion Forceps sterile or non-sterile when supplied?

    The Avulsion Forceps is supplied non-sterile and is intended for reusable use following appropriate cleaning, disinfection, and sterilization reprocessing between uses.

  • What is the regulatory pathway and clearance number for the Avulsion Forceps?

    The Avulsion Forceps (K183428) received FDA 510(k) clearance on April 16, 2019, under the traditional pathway, with regulation number 876.4300 and product code KGE, confirming substantial equivalence to a predicate device.