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)
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.

View all Tissue Science Laboratories, Plc devices

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
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 97
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K013625.
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K030782 · W.L. Gore & Associates, Inc. · Apr 2003
DERMMATRIX SURGICAL MESH
K021160 · Carbon Medical Technologies, Inc. · Jun 2002
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K020455 · Tei Biosciences, Inc. · Apr 2002
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K001738 · DePuy Orthopaedics, Inc. · Dec 2000
TUTOPATCH
K991296 · Tutogen Medical U.S., Inc. · Oct 2000
PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED
K992537 · Bio-Vascular, Inc. · Feb 2000