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AC5 Advanced Wound System AC5-1001

by Arch Therapeutics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB665AC510011 UDI-DI Date24 Jul 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
AC5 Advanced Wound System
Generic Name
Synthetic peptide haemostatic agent
Model / Ref / Catalog
AC5-1001
Primary DI / UDI-DI
B665AC510011
510(k) Number
FDA Product Code
FRO
GMDN Term
Synthetic peptide haemostatic agent
Device Class
U
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K190129)

Other devices from Arch Therapeutics, Inc.

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No