510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160869Substantially Equivalent

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft

Cook Biotech Incorporated, West Lafayette IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160869 is the FDA 510(k) clearance record for Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft, a class II device, cleared for Cook Biotech Incorporated on under FDA product code FTM (Mesh, Surgical). FDA records list 16 510(k) clearances for Cook Biotech Incorporated, from to . As of , FDA records show one recall naming K160869.

Clearance record

Decision date
Received
(30 days to decision)
Product code
FTM Mesh, Surgical
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cook Biotech Incorporated 1425 Innovation Pl., West Lafayette IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTM

Trailing 12 months
1 clearance under product code FTM in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FTM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260