Cleared Special

K040472 - FORCE FIBER BLUE CO-BRAIDED POLYETHYLEN...

K040472 is the FDA 510(k) clearance for FORCE FIBER BLUE CO-BRAIDED POLYETHYLEN... by Teleflex Medical. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Special 510(k) pathway after a 20-day FDA review.

K040472 · Teleflex Medical · General & Plastic Surgery device
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Mar 2004
Decision
20d
Days
Class 2
Risk

K040472 is an FDA 510(k) clearance for the FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Teleflex Medical (Durham, US). The FDA issued a Cleared decision on March 15, 2004 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Teleflex Medical devices

Submission Details

510(k) Number K040472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2004
Decision Date March 15, 2004
Days to Decision 20 days
Submission Type Special
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
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 94
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K040472.
ARTHREX FIBERWIRE WITH SILK
K041589 · Arthrex, Inc. · Aug 2004
SMITH & NEPHEW ULTRABRAID SUTURE
K041216 · Smith & Nephew, Inc. · Jun 2004
DURABRAID SUTURE
K040789 · Smith & Nephew, Inc. · Jun 2004
FORCE FIBER
K033654 · Teleflex Medical · Jan 2004
ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239
K032245 · Arthrex, Inc. · Jan 2004
STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM
K032901 · Stryker Endoscopy · Dec 2003