Cleared Traditional

K070560 - LRTM SURGICAL MESH

K070560 is an FDA 510(k) clearance for LRTM 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 104-day FDA review.

K070560 · Lifecell Corp. · General & Plastic Surgery device
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Jun 2007
Decision
104d
Days
Class 2
Risk

K070560 is an FDA 510(k) clearance for the LRTM 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 June 11, 2007 after a review of 104 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 - K070560

510(k) Number K070560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2007
Decision Date June 11, 2007
Days to Decision 104 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
11d faster than avg
Panel avg: 115d · This submission: 104d
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 K070560.
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
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BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106
K063178 · C.R. Bard, Inc. · Nov 2006
SURGISIS, SURGISIS ES
K062696 · Cook Biotech, Inc. · Oct 2006