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Omed Wound Closure Strips

by Oxboro Medical Intl., Inc.

510(k) K874813

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 NumberK874813 Date29 Jan 1988ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1988-2013 FDA Class II initiated 18 Jul 2013

    Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment including the use of antibiotics. There have been no reports of injuries or illnesses as of 7/18/2013.

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  • Withdrawn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
FPX
Device Class
Class I
Regulation
21 CFR Part 880.5240
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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