Skip to content

Biodesign G12579

by Cook Biotech Incorporated 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K160869; other models may be affected

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810179631079 UDI-DI Date4 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0834-2025 FDA Class II initiated 22 Nov 2024 on shared 510(k) K160869

    Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Biodesign
Generic Name
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Model / Ref / Catalog
G12579, C-SLH-4S-7X20
Primary DI / UDI-DI
00810179631079
510(k) Number
FDA Product Code
FTM
GMDN Term
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Device Class
Class II
Regulation Number
878.3300
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K160869)

Show all (12)

Cleared under the same submission (K980431)

Show all (12)

Other devices from Cook Biotech Incorporated

See all devices from Cook Biotech Incorporated →

Properties

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

Other properties (8)

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