Skip to content

Silicone PHMB Foam Wound Dressing

by Advanced Medical Solutions Ltd

510(k) K190819

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190819 Date25 Jul 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
FDA applicant
Advanced Medical Solutions, Ltd.
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

Other devices from Advanced Medical Solutions Limited

See all devices from Advanced Medical Solutions Limited →