Cleared Traditional

K061473 - SURGI-WRAP MAST BIORESORBABLE SHEET

K061473 is an FDA 510(k) clearance for SURGI-WRAP MAST BIORESORBABLE SHEET, manufactured by Mast Biosurgery USA, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K061473 · Mast Biosurgery USA, Inc. · General & Plastic Surgery device
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Sep 2006
Decision
114d
Days
Class 2
Risk

K061473 is an FDA 510(k) clearance for the SURGI-WRAP MAST BIORESORBABLE SHEET. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Mast Biosurgery USA, Inc. (San Diego, US). The FDA issued a Cleared decision on September 21, 2006 after a review of 114 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 Mast Biosurgery USA, Inc. devices

FDA 510(k) Submission Details - K061473

510(k) Number K061473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2006
Decision Date September 21, 2006
Days to Decision 114 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
1d faster than avg
Panel avg: 115d · This submission: 114d
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 220
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K061473.
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
K063435 · W.L. Gore & Associates, Inc. · Nov 2006
BARD COMPOSITE L/P MESH
K061754 · Davol Inc., Sub. C. R. Bard, Inc. · Oct 2006
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
K062697 · Cook Biotech, Inc. · Oct 2006
OPTILENE MESH
K061704 · Aesculap, Inc. · Jul 2006
SURGICAL MESH SYSTEM
K053215 · Nuvasive, Inc. · Jul 2006
BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH
K061314 · Davol Inc., Sub. C. R. Bard, Inc. · Jun 2006