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Sharpoint Polypropylene Nonabsorb Surg Sutures Usp

by Chathamborough Research Group, Inc.

510(k) K904906

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK904906 Date24 Dec 1990ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2042-2016 FDA Class II initiated 20 May 2016

    Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.

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  • Withdrawn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
GAW
Device Class
Class II
Regulation
21 CFR Part 878.5010
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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