Cleared Traditional

K041669 - VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD

K041669 is an FDA 510(k) clearance for VERITAS DRY COLLAGEN MATRIX, manufactured by Synovis Surgical Innovations. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K041669 · Synovis Surgical Innovations · General & Plastic Surgery device
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Oct 2004
Decision
128d
Days
Class 2
Risk

K041669 is an FDA 510(k) clearance for the VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Synovis Surgical Innovations (St. Paul, US). The FDA issued a Cleared decision on October 27, 2004 after a review of 128 days - within the typical 510(k) review window.

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 Synovis Surgical Innovations devices

FDA 510(k) Submission Details - K041669

510(k) Number K041669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2004
Decision Date October 27, 2004
Days to Decision 128 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
13d slower than avg
Panel avg: 115d · This submission: 128d
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 77
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K041669.
BIOBLANKET SURGICAL MESH
K043259 · Kensey Nash Corp. · Aug 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
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
K040756 · Implex Corp. · Jul 2004
ACELL UBM SURGICAL MESH ML AND MLPLUS
K041140 · Acell, Inc. · Jul 2004