Cleared Traditional

K133011 - DIAPHRAGMATIC HERNIA GRAFT

K133011 is the FDA 510(k) clearance for DIAPHRAGMATIC HERNIA GRAFT by Cook Biotech, Inc.. It is a Class 2 General & Plastic Surgery device (product code OWV) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K133011 · Cook Biotech, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
268d
Days
Class 2
Risk

K133011 is an FDA 510(k) clearance for the DIAPHRAGMATIC HERNIA GRAFT. Classified as Mesh, Surgical, Collagen, Diaphragmatic Hernia (product code OWV), Class II - Special Controls.

Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on June 20, 2014 after a review of 268 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Biotech, Inc. devices

Submission Details

510(k) Number K133011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2013
Decision Date June 20, 2014
Days to Decision 268 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 115d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OWV Mesh, Surgical, Collagen, Diaphragmatic Hernia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Diaphragmatic Hernia Repair.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00272922 Completed Interventional Industry-sponsored

Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)

150
Patients (est.)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Hernia; Paraesophageal Hernia
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Brant K Oelschlager, MD
Sponsor Cook Group Incorporated (industry)
Started 2002-07-01 → Completed 2006-07-01
Study completed - no results published. This trial concluded in 2006 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov