Cleared Special

K060163 - CARDIOFLON

K060163 is an FDA 510(k) clearance for CARDIOFLON, manufactured by Peters Surgical. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Special 510(k) pathway after a 261-day FDA review.

K060163 · Peters Surgical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
261d
Days
Class 2
Risk

K060163 is an FDA 510(k) clearance for the CARDIOFLON, CARDIOXYL. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Peters Surgical (Bobigny, FR). The FDA issued a Cleared decision on October 11, 2006 after a review of 261 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Peters Surgical devices

FDA 510(k) Submission Details - K060163

510(k) Number K060163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2006
Decision Date October 11, 2006
Days to Decision 261 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 115d · This submission: 261d
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 107
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K060163.
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TENOLIG
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ALLOFIX ANCHOR
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K052652 · Smith & Nephew, Inc. · Oct 2005