Cleared Abbreviated

FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE (K063778) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 115d · This submission: 50d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 173
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K063778.
Polyethylene
K260775 · Teleflex Medical, LLC · May 2026
HyperSuture All Green Extension Line
K254275 · Threadstone, LLC · Mar 2026
Meniscus Versaflex
K254188 · GM Dos Reis Industria e Comercio Ltda. · Feb 2026
Pre-Sutured Tendon
K253145 · Rti Surgical, Inc. · Oct 2025
ProZip Knotless Implant
K253024 · Riverpoint Medical · Oct 2025
PowerKnot High Strength Sutures
K252225 · Medacta International S.A. · Sep 2025