Cleared Abbreviated

K063778 - FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE

K063778 is an FDA 510(k) clearance for FORCE FIBER POLYETHYLENE NONABSORBABLE ..., manufactured by Teleflex Medical. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Abbreviated 510(k) pathway after a 50-day FDA review.

K063778 · Teleflex Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
50d
Days
Class 2
Risk

K063778 is an FDA 510(k) clearance for the FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Teleflex Medical (Bannockburn, US). The FDA issued a Cleared decision on February 9, 2007 after a review of 50 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Teleflex Medical devices

FDA 510(k) Submission Details - K063778

510(k) Number K063778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2006
Decision Date February 09, 2007
Days to Decision 50 days
Submission Type Abbreviated
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
65d faster than avg
Panel avg: 115d · This submission: 50d
Pathway characteristics
Standards-based clearance path.

GAT Device Classification - Class 2, Special Controls

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 141
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K063778.
AXYA SUTURE WELDING SYSTEM AND KIT
K070253 · Axya Medical, Inc. · Jul 2007
ARTHREX FIBERWIRE
K071622 · Arthrex, Inc. · Jul 2007
FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE
K070673 · Teleflexmedical, Inc. · Apr 2007
TUFFLEX POLYESTER SUTURE
K063194 · Axya Medical, Inc. · Dec 2006
AXYAFLEX POLYESTER SUTURE
K060165 · Axya Medical, Inc. · Sep 2006
TENOLIG
K060367 · Fournitures Hospitalieres Industrie · Aug 2006