Cleared Traditional

K063648 - SURGI-WRAP MAST TENDON SHEET

K063648 is an FDA 510(k) clearance for SURGI-WRAP MAST TENDON 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 90-day FDA review.

K063648 · Mast Biosurgery USA, Inc. · General & Plastic Surgery device
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Mar 2007
Decision
90d
Days
Class 2
Risk

K063648 is an FDA 510(k) clearance for the SURGI-WRAP MAST TENDON 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 March 7, 2007 after a review of 90 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 - K063648

510(k) Number K063648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2006
Decision Date March 07, 2007
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 K063648.
ULTRAPRO PLUG
K070224 · Ethicon, Inc. · Apr 2007
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
K070644 · W.L. Gore & Associates, Inc. · Apr 2007
ATRIUM PROLITE ULTRA S MESH
K070192 · Atrium Medical Corp. · Mar 2007
PROCEED VENTRAL PATCH
K061533 · Ethicon, Inc. · Dec 2006
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