Cleared Special

K100229 - VENTRIO HERNIA PATCH

K100229 is the FDA 510(k) clearance for VENTRIO HERNIA PATCH by C.R. Bard, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Special 510(k) pathway after a 85-day FDA review.

K100229 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
85d
Days
Class 2
Risk

K100229 is an FDA 510(k) clearance for the VENTRIO HERNIA PATCH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on April 21, 2010 after a review of 85 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K100229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2010
Decision Date April 21, 2010
Days to Decision 85 days
Submission Type Special
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
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 157
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K100229.
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
K102766 · C.R. Bard, Inc. · Dec 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
K100787 · Smith & Nephew, Inc. · Sep 2010
TORNIER SURGICAL MESH
K093799 · Tornier, Inc. · Apr 2010
ATRIUM C-QUR OVT MESH
K100076 · Atrium Medical Corp. · Jan 2010
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
K091659 · C.R. Bard, Inc. · Aug 2009
C-QUR V -PATCH MESH
K090909 · Atrium Medical Corp. · Jun 2009