Cleared Traditional

K063536 - POLYSORB* SYNTHETIC ABSORBABLE SUTURE W...

K063536 is an FDA 510(k) clearance for POLYSORB* SYNTHETIC ABSORBABLE SUTURE W..., manufactured by Tyco Healthcare Group. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K063536 · Tyco Healthcare Group · General & Plastic Surgery device
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Jan 2007
Decision
68d
Days
Class 2
Risk

K063536 is an FDA 510(k) clearance for the POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Tyco Healthcare Group (Norwalk, US). The FDA issued a Cleared decision on January 29, 2007 after a review of 68 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tyco Healthcare Group devices

FDA 510(k) Submission Details - K063536

510(k) Number K063536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2006
Decision Date January 29, 2007
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAM Device Classification - Class 2, Special Controls

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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