Cleared Traditional

K953577 - BARD VISILEX MESH 3 X 6

K953577 is an FDA 510(k) clearance for BARD VISILEX MESH 3 X 6, 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 57-day FDA review.

K953577 · Davol Inc., Sub. C. R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
57d
Days
Class 2
Risk

K953577 is an FDA 510(k) clearance for the BARD VISILEX MESH 3 X 6. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Davol Inc., Sub. C. R. Bard, Inc. (Canston, US). The FDA issued a Cleared decision on September 26, 1995 after a review of 57 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 Davol Inc., Sub. C. R. Bard, Inc. devices

FDA 510(k) Submission Details - K953577

510(k) Number K953577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1995
Decision Date September 26, 1995
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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 198
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K953577.
GORE-TEX MYCROMESH BIOMATERIAL
K951675 · W.L. Gore & Associates, Inc. · Oct 1995
GORE-TEX DUALMESH BIOMATERIAL
K951676 · W.L. Gore & Associates, Inc. · Oct 1995
GORE-TEX SOFT TISSUE PATCH
K951700 · W.L. Gore & Associates, Inc. · Oct 1995
GORE-TEX DUALMESH PLUS BIOMATERIAL
K946106 · W.L. Gore & Associates, Inc. · Apr 1995
GORE-TEX MYCROMESH PLUS BIOMATERIAL
K946107 · W.L. Gore & Associates, Inc. · Apr 1995
GORE-TEX(R) CURVED SURGICALMEMBRANE
K945899 · W.L. Gore & Associates, Inc. · Feb 1995