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ActivHeal Silver Alginate

by Advanced Medical Solutions Limited 6 variants

ActivHeal Silver Alginate (9023281) is a device classified as Unclassified made by Advanced Medical Solutions Limited, cleared under FDA 510(k) K080503 on 12 Nov 2008 and listed in FDA GUDID since 3 May 2023 (UDI-DI 15032749023288), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K080503

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15032749023288 UDI-DI Date3 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK080503 Date12 Nov 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K080503 decided 12 Nov 2008 Active
  • FDA GUDID UDI-DI 15032749023288 listed 3 May 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K080503
  2. Listed FDA GUDID 15032749023288

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ActivHeal
Generic name
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Model / Ref / Catalog
Silver Alginate, 9023281
Primary DI / UDI-DI
15032749023288
510(k) Number
FDA product code
FRO
GMDN term
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Device class
U
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Cleared under the same submission (K080503)

and 1 more cleared under K080503

Similar devices

Other devices filed under FDA product code FRO (Dressing, Wound, Drug).

Other devices from Advanced Medical Solutions Limited

See all devices from Advanced Medical Solutions Limited →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Combination product
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)