Cleared Traditional

K060165 - AXYAFLEX POLYESTER SUTURE

K060165 is an FDA 510(k) clearance for AXYAFLEX POLYESTER SUTURE, manufactured by Axya Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K060165 · Axya Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
221d
Days
Class 2
Risk

K060165 is an FDA 510(k) clearance for the AXYAFLEX 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 September 1, 2006 after a review of 221 days - an extended review 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K060165

510(k) Number K060165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2006
Decision Date September 01, 2006
Days to Decision 221 days
Submission Type Traditional
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
106d slower than avg
Panel avg: 115d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 175
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K060165.
G-PROX ENDOSCOPIC GRASPER
K061276 · Usgi Medical · Dec 2006
TUFFLEX POLYESTER SUTURE
K063194 · Axya Medical, Inc. · Dec 2006
CARDIOFLON, CARDIOXYL
K060163 · Peters Surgical · Oct 2006
XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS
K062307 · Anulex Technologies, Inc. · Sep 2006
TENOLIG
K060367 · Fournitures Hospitalieres Industrie · Aug 2006
ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB
K061386 · Anulex Technologies, Inc. · Jul 2006
K060165 · AXYAFLEX POLYESTER SUTURE
Download PDF FDA Summary Axya Medical, Inc.