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Biopsy Needles & Trays

by American Pharmaseal Div. Ahsc

510(k) K813338

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK813338 Date28 Jan 1982ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2668-2026 FDA Class II initiated 21 May 2026

    Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

    • Terminated Z-1422-2018 FDA Class II initiated 23 Feb 2017

    The integrity of the sterile packaging is potentially compromised.

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  • Withdrawn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
FSH
Device Class
Class I
Regulation
21 CFR Part 878.4800
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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