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Biodesign G54201

by Cook Biotech Incorporated 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

12 ongoing

This device is named in the recall

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 Number00810179630799 UDI-DI Date4 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

12 recalls · 12 ongoing · FDA

  • 12 recalls, same reason

    • Ongoing Z-3261-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3260-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3257-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3252-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3256-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3255-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3251-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3259-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3254-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3258-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3250-2024 FDA Class II initiated 7 Aug 2024
    • Ongoing Z-3253-2024 FDA Class II initiated 7 Aug 2024

    Products expire prior to the expiration date printed on the product labeling

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  • Withdrawn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
Fistula-repair biomatrix implant
Model / Ref / Catalog
G54201, C-FP-0.4
Primary DI / UDI-DI
00810179630799
510(k) Number
FDA Product Code
FTM
GMDN Term
Fistula-repair biomatrix implant
Device Class
Class II
Regulation Number
878.3300
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K062729)

Show all (11)

Cleared under the same submission (K170016)

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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
  • Manufacturing Date

Other properties (7)

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