Cleared Traditional

K043259 - BIOBLANKET SURGICAL MESH

K043259 is an FDA 510(k) clearance for BIOBLANKET SURGICAL MESH, manufactured by Kensey Nash Corp.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K043259 · Kensey Nash Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
264d
Days
Class 2
Risk

K043259 is an FDA 510(k) clearance for the BIOBLANKET SURGICAL MESH. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Kensey Nash Corp. (Exton, US). The FDA issued a Cleared decision on August 15, 2005 after a review of 264 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 Kensey Nash Corp. devices

FDA 510(k) Submission Details - K043259

510(k) Number K043259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2004
Decision Date August 15, 2005
Days to Decision 264 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
149d slower than avg
Panel avg: 115d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

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 76
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K043259.
TENDON WRAP TENDON PROTECTOR
K053655 · Integra LifeSciences Corporation · Feb 2006
SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
K051879 · Synthes (Usa) · Oct 2005
SURGISIS STAPLE LINE REINFORCEMENT II
K051048 · Cook Biotech, Inc. · Sep 2005
SIS DERMAL AUGMENTATION STRAND
K050246 · Cook Biotech, Inc. · May 2005
SIS FISTULA PLUG
K050337 · Cook Biotech, Inc. · Mar 2005
BIOBLANKET
K041923 · Kensey Nash Corp. · Sep 2004