Cleared Traditional

K082176 - LTM-BPS SURGICAL MESH

K082176 is an FDA 510(k) clearance for LTM-BPS SURGICAL MESH, manufactured by Lifecell Corp.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K082176 · Lifecell Corp. · General & Plastic Surgery device
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Nov 2008
Decision
105d
Days
Class 2
Risk

K082176 is an FDA 510(k) clearance for the LTM-BPS SURGICAL MESH. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Lifecell Corp. (Branchburg, US). The FDA issued a Cleared decision on November 14, 2008 after a review of 105 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 Lifecell Corp. devices

FDA 510(k) Submission Details - K082176

510(k) Number K082176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2008
Decision Date November 14, 2008
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
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 K082176.
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