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Holmed Hand Held Instruments

by Performance Surgical Instruments Corp.

510(k) K913810

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 NumberK913810 Date19 Dec 1991ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

Holmed Hand Held Instruments are manual gastroenterology-urology surgical instruments. They are substantially equivalent to predicate devices as determined by FDA 510(k) clearance K913810.

The device is supplied by Performance Surgical Instruments Corp. and is intended for use in clinical settings requiring manual control of attached surgical instruments. It is a reusable instrument, with no sterility or single-use claims indicated in the data, and is not described as MRI safe or unsafe. Storage conditions and specific sizes are not provided in the specifications.

Other devices from Performance Surgical Instruments Corp.