Cleared Traditional

K013625 - PERMACOL

K013625 is an FDA 510(k) clearance for PERMACOL, manufactured by Tissue Science Laboratories, Plc. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K013625 · Tissue Science Laboratories, Plc · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
73d
Days
Class 2
Risk

K013625 is an FDA 510(k) clearance for the PERMACOL. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Tissue Science Laboratories, Plc (Washington, US). The FDA issued a Cleared decision on January 17, 2002 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K013625

510(k) Number K013625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2001
Decision Date January 17, 2002
Days to Decision 73 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
42d faster than avg
Panel avg: 115d · This submission: 73d
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 163
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K013625.
FORTAFLEX SURGICAL MESH
K021105 · Organogenesis, Inc. · May 2002
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K020455 · Tei Biosciences, Inc. · Apr 2002
FORTAFLEX SURGICAL MESH
K020049 · Organogenesis, Inc. · Mar 2002
FORTAFLEX SURGICAL MESH
K011025 · Organogenesis, Inc. · Aug 2001
FORTAFLEX SURGICAL SLING
K011027 · Organogenesis, Inc. · May 2001
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K001738 · DePuy Orthopaedics, Inc. · Dec 2000
K013625 · PERMACOL
Download PDF FDA Summary Tissue Science Labora…