Cleared Traditional

K013664 - COALESCENT SURGICAL U-CLIP

K013664 is an FDA 510(k) clearance for COALESCENT SURGICAL U-CLIP, manufactured by Coalescent Surgical. The device is a Class 2 General & Plastic Surgery device with product code NCA cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K013664 · Coalescent Surgical · General & Plastic Surgery device
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Jan 2002
Decision
79d
Days
Class 2
Risk

K013664 is an FDA 510(k) clearance for the COALESCENT SURGICAL U-CLIP. Classified as Clip, Implantable, For Coronary Artery Bypass Graft (cabg) (product code NCA), Class II - Special Controls.

Submitted by Coalescent Surgical (Sunnyvale, US). The FDA issued a Cleared decision on January 24, 2002 after a review of 79 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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 Coalescent Surgical devices

FDA 510(k) Submission Details - K013664

510(k) Number K013664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2001
Decision Date January 24, 2002
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NCA Device Classification - Class 2, Special Controls

Product Code NCA Clip, Implantable, For Coronary Artery Bypass Graft (cabg)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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.