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AQUACEL Ag Surgical SP Dressing

by Convatec Limited

510(k) K152926

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 · Special NumberK152926 Date21 Jan 2016ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2677-2026 FDA Class II initiated 8 Jun 2026

    Surgical dressing manufactured out of specification (greater thickness).

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  • Withdrawn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
FRO
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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