Cleared Special

K063194 - TUFFLEX POLYESTER SUTURE

K063194 is an FDA 510(k) clearance for TUFFLEX POLYESTER SUTURE, manufactured by Axya Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Special 510(k) pathway after a 45-day FDA review.

K063194 · Axya Medical, Inc. · General & Plastic Surgery device
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Dec 2006
Decision
45d
Days
Class 2
Risk

K063194 is an FDA 510(k) clearance for the TUFFLEX POLYESTER SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Axya Medical, Inc. (Beverly, US). The FDA issued a Cleared decision on December 4, 2006 after a review of 45 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 Axya Medical, Inc. devices

FDA 510(k) Submission Details - K063194

510(k) Number K063194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2006
Decision Date December 04, 2006
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

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 K063194.
ARTHREX FIBERWIRE
K071622 · Arthrex, Inc. · Jul 2007
FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE
K070673 · Teleflexmedical, Inc. · Apr 2007
FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE
K063778 · Teleflex Medical · Feb 2007
AXYAFLEX POLYESTER SUTURE
K060165 · Axya Medical, Inc. · Sep 2006
TENOLIG
K060367 · Fournitures Hospitalieres Industrie · Aug 2006
ALLOFIX ANCHOR
K053339 · Musculoskeletal Transplant Foundation · Mar 2006