Cleared Traditional

K102766 - COMPOSIX L/P MESH WITH ECHO PS POSITION...

K102766 is the FDA 510(k) clearance for COMPOSIX L/P MESH WITH ECHO PS POSITION... by C.R. Bard, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K102766 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
83d
Days
Class 2
Risk

K102766 is an FDA 510(k) clearance for the COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM. 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 December 16, 2010 after a review of 83 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

Submission Details

510(k) Number K102766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2010
Decision Date December 16, 2010
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K102766.
VENTRIO ST HERNIA PATCH
K101920 · C.R. Bard, Inc. · Mar 2011
VENTRALEX ST HERNIA PATCH
K101928 · C.R. Bard, Inc. · Mar 2011
RESTORELLE POLYPROPYLENE MESH
K103568 · Coloplast A/S · Dec 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
K100787 · Smith & Nephew, Inc. · Sep 2010
TORNIER SURGICAL MESH
K093799 · Tornier, Inc. · Apr 2010
VENTRIO HERNIA PATCH
K100229 · C.R. Bard, Inc. · Apr 2010