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Seriscaffold Surgical Mesh

by Serica Technologies, Inc.

510(k) K080442

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 NumberK080442 Date13 Nov 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0794-2013 FDA Class II initiated 8 Jan 2013

    Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured

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  • Withdrawn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
FTL
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent