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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 156
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K070560.
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K071016 · DePuy Orthopaedics, Inc. · Sep 2007
ORTHOMEND SOFT TISSUE MATRIX
K071807 · Tei Biosciences, Inc. · Aug 2007
MESOSFOL SURGICAL FILM
K062558 · Biomet Manufacturing Corp · Jun 2007
ORTHADAPT BIOIMPLANT
K071065 · Pegasus Biologics, Inc. · May 2007
SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
K070738 · Cook Biotech, Inc. · Apr 2007
PERIPATCH ENDO-SLEEVE
K063556 · Pm Devices, Inc. · Mar 2007
K070560 · LRTM SURGICAL MESH
Download PDF FDA Summary Lifecell Corp.