Cleared Traditional

K092032 - BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160

K092032 is an FDA 510(k) clearance for BARD PERFIX LIGHT PLUG, manufactured by Davol Inc., Sub. 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 155-day FDA review.

K092032 · Davol Inc., Sub. C. R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
155d
Days
Class 2
Risk

K092032 is an FDA 510(k) clearance for the BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0.... Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Davol Inc., Sub. C. R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on December 8, 2009 after a review of 155 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 Davol Inc., Sub. C. R. Bard, Inc. devices

FDA 510(k) Submission Details - K092032

510(k) Number K092032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date December 08, 2009
Days to Decision 155 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
40d slower than avg
Panel avg: 115d · This submission: 155d
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 325
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K092032.
ATRIUM C-QUR OVT MESH
K100076 · Atrium Medical Corp. · Jan 2010
TIGR SURGICAL MESH , MODEL WK-6
K092224 · Novus Scientific Pte, Ltd. · Jan 2010
HYDROCOAT MESH
K090271 · Promethean Surgical Devices, Inc. · Jan 2010
WITTMANN PATCH
K093166 · Aperta, LLC · Dec 2009
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