510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191696Substantially Equivalent

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft

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

K191696 is the FDA 510(k) clearance record for Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft, a class II device, cleared for Cook Biotech Incorporated on under FDA product code OXN (Mesh, Surgical, Collagen, Fistula). FDA's definition for product code OXN reads: "For reinforcement of soft tissue where weakness exists during the repair of fistulas". FDA records list 16 510(k) clearances for Cook Biotech Incorporated, from to . As of , FDA records show no recalls naming K191696.

Clearance record

Decision date
Received
(185 days to decision)
Product code
OXN Mesh, Surgical, Collagen, Fistula
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 OXN

Trailing 12 months

FDA records hold no clearances under product code OXN in the trailing twelve months.

FDA records show no clearances under product code OXN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OXN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260