Cleared Traditional

K081272 - PORCINE SURGICAL MESH

Also marketed or referenced as:
DERMAL MATRIX

K081272 is an FDA 510(k) clearance for PORCINE SURGICAL MESH, manufactured by Brennen Medical, LLC. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K081272 · Brennen Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
87d
Days
Class 2
Risk

K081272 is an FDA 510(k) clearance for the PORCINE SURGICAL MESH. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Brennen Medical, LLC (St. Paul, US). The FDA issued a Cleared decision on July 31, 2008 after a review of 87 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 Brennen Medical, LLC devices

FDA 510(k) Submission Details - K081272

510(k) Number K081272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2008
Decision Date July 31, 2008
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
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 90
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K081272.
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
K082682 · Cook Biotech, Inc. · Feb 2009
SURGIMEND
K083898 · Tei Biosciences, Inc. · Feb 2009
COLLAMEND FM IMPLANT
K082687 · C.R. Bard, Inc. · Oct 2008
COLLAGEN TENDON WRAP
K080452 · Collagen Matrix, Inc. · May 2008
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08
K073219 · American Medical Systems, Inc. · Apr 2008
SURGISIS BIODESIGN TISSUE GRAFT
K073391 · Cook Biotech, Inc. · Mar 2008