Cleared Traditional

K080442 - SERISCAFFOLD SURGICAL MESH

K080442 is an FDA 510(k) clearance for SERISCAFFOLD SURGICAL MESH, manufactured by Serica Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K080442 · Serica Technologies, Inc. · General & Plastic Surgery device
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Nov 2008
Decision
268d
Days
Class 2
Risk

K080442 is an FDA 510(k) clearance for the SERISCAFFOLD SURGICAL MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Serica Technologies, Inc. (Medford, US). The FDA issued a Cleared decision on November 13, 2008 after a review of 268 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 Serica Technologies, Inc. devices

FDA 510(k) Submission Details - K080442

510(k) Number K080442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2008
Decision Date November 13, 2008
Days to Decision 268 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
153d slower than avg
Panel avg: 115d · This submission: 268d
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 225
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K080442.
GORE BIO-A FISTULA PLUG
K083266 · W.L. Gore & Associates, Inc. · Mar 2009
NUVASIVE SURGICAL MESH SYSTEM
K081377 · Nuvasive, Inc. · Jan 2009
ATRIUM PROLITE S MESH
K082748 · Atrium Medical Corp. · Jan 2009
BARD 3DMAX MESH
K081010 · Davol Inc., Sub. C. R. Bard, Inc. · Oct 2008
VENTRIO HERNIA PATCH
K081777 · C.R. Bard, Inc. · Sep 2008
SUPRAMESH EXTRA
K080216 · S. Jackson, Inc. · Sep 2008