DIAPHRAGMATIC HERNIA GRAFT— 510(k) K133011

Substantially Equivalent

Cook Biotech, Inc.

FDA 510(k) clearance K133011 for DIAPHRAGMATIC HERNIA GRAFT, Substantially Equivalent on 2014-06-20. Applicant: Cook Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Cook Biotech, Inc.
Product code: Code OWV
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2013-09-25
Decision date: 2014-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

More clearances from Cook Biotech, Inc.

K133306 — SIS HERNIA GRAFT2014-07-23
K131015 — BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT2013-10-08
K111695 — HYBRID GRAFT2012-04-02
K110402 — BIODESIGN NIPPLE RECONSTRUCTION CYLINDER2011-06-20
K090688 — COOK UROLOGICAL GRAFT2009-07-10

Recalls naming K133011

K-number listed on FDA's recall record

Z-0833-2025 — Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; andClass II·Ongoing·Cook Biotech, Inc.·20241122

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133011.

Data sourced from openFDA. This site is unofficial and independent of the FDA.