510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K133011Substantially Equivalent

Diaphragmatic Hernia Graft

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

K133011 is the FDA 510(k) clearance record for DIAPHRAGMATIC HERNIA GRAFT, a class II device, cleared for Cook Biotech, Inc. on under FDA product code OWV (Mesh, Surgical, Collagen, Diaphragmatic Hernia). FDA's definition for product code OWV reads: "For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair". FDA records list 31 510(k) clearances for Cook Biotech, Inc., from to . As of , FDA records show one recall naming K133011.

Clearance record

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

Clearances, product code OWV

Trailing 12 months

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

FDA records show no clearances under product code OWV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OWV, 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