Cleared Special

K082748 - ATRIUM PROLITE S MESH

K082748 is an FDA 510(k) clearance for ATRIUM PROLITE S MESH, manufactured by Atrium Medical Corp.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Special 510(k) pathway after a 117-day FDA review.

K082748 · Atrium Medical Corp. · General & Plastic Surgery device
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Jan 2009
Decision
117d
Days
Class 2
Risk

K082748 is an FDA 510(k) clearance for the ATRIUM PROLITE S MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on January 14, 2009 after a review of 117 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Atrium Medical Corp. devices

FDA 510(k) Submission Details - K082748

510(k) Number K082748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2008
Decision Date January 14, 2009
Days to Decision 117 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 115d · This submission: 117d
Pathway characteristics
Modification to existing cleared device.

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 325
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K082748.
GORE BIO-A FISTULA PLUG
K083266 · W.L. Gore & Associates, Inc. · Mar 2009
SYNTHASOME X-REPAIR
K083307 · Synthasome, Inc. · Mar 2009
NUVASIVE SURGICAL MESH SYSTEM
K081377 · Nuvasive, Inc. · Jan 2009
BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
K082941 · Biomerix Corporation · Jan 2009
SERISCAFFOLD SURGICAL MESH
K080442 · Serica Technologies, Inc. · Nov 2008
BARD 3DMAX MESH
K081010 · Davol Inc., Sub. C. R. Bard, Inc. · Oct 2008