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ACTICOAT Flex 66027685

by Smith & Nephew Medical, Ltd.

ACTICOAT Flex 66027685 is a device classified as Unclassified made by Smith & Nephew Medical, Ltd., cleared under FDA 510(k) K083113 on 22 Jul 2009 and listed in FDA GUDID since 28 Apr 2026 (UDI-DI 05000223502249), active as of 22 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 22 Oct 2026

Documents

510(k) K083113

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05000223502249 UDI-DI Date28 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK083113 Date22 Jul 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083113 decided 22 Jul 2009 Active
  • FDA GUDID UDI-DI 05000223502249 listed 28 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K083113
  2. Listed FDA GUDID 05000223502249

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ACTICOAT Flex
Generic name
Wound-nonadherent dressing, absorbent, antimicrobial
Model / Ref / Catalog
66027685
Primary DI / UDI-DI
05000223502249
510(k) Number
FDA product code
FRO
GMDN term
Wound-nonadherent dressing, absorbent, antimicrobial
Device class
U
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Width — 4 Inch
Length — 5 Inch

Related devices

Cleared under the same submission (K083113)

and 8 more cleared under K083113

Similar devices

Other devices filed under FDA product code FRO (Dressing, wound, drug).

Other devices from Smith & Nephew Medical, Ltd.

See all devices from Smith & Nephew Medical, Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)