Cleared Traditional

K021736 - BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301

K021736 is an FDA 510(k) clearance for BARD VENTRALEX HERNIA PATCH, manufactured by C.R. Bard, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K021736 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
49d
Days
Class 2
Risk

K021736 is an FDA 510(k) clearance for the BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Canston, US). The FDA issued a Cleared decision on July 16, 2002 after a review of 49 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K021736

510(k) Number K021736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2002
Decision Date July 16, 2002
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 267
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K021736.
BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
K021835 · Brennen Medical, Inc. · Oct 2002
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
K022782 · W.L. Gore & Associates, Inc. · Sep 2002
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
K022350 · C.R. Bard, Inc. · Aug 2002
MACROPORE SURGIWRAP (TS)
K012025 · Macropore Biosurgery, Inc. · Dec 2001
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
K010722 · Ethicon, Inc. · Apr 2001
IVS TUNNELLER
K010035 · United States Surgical, A Division of Tyco Healthc · Apr 2001