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Lukens Pga, (Polyglycolic Acid) Synthetic Absorbable Surgical Suture, Coated, Braided-U.S.P.

by Lukens Medical Corp.

510(k) K965162

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 NumberK965162 Date12 Feb 1997ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1534-2024 FDA Class II initiated 26 Mar 2024

    Complaints have been received with allegations of Incorrect Needle Curvature.

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  • Withdrawn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
GAM
Device Class
Class II
Regulation
21 CFR Part 878.4493
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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