Cleared Abbreviated

K031332 - BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH

K031332 is the FDA 510(k) clearance for BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH by C.R. Bard, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTM) cleared through the Abbreviated 510(k) pathway after a 17-day FDA review.

K031332 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
17d
Days
Class 2
Risk

K031332 is an FDA 510(k) clearance for the BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on May 15, 2003 after a review of 17 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K031332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2003
Decision Date May 15, 2003
Days to Decision 17 days
Submission Type Abbreviated
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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FTM Mesh, Surgical
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 - FTM Mesh, Surgical

All 44
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K031332.
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