Cleared Traditional

K053524 - C-PORT DISTAL ANASTOMOSIS SYSTEM

K053524 is an FDA 510(k) clearance for C-PORT DISTAL ANASTOMOSIS SYSTEM, manufactured by Cardica, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K053524 · Cardica, Inc. · General & Plastic Surgery device
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Nov 2006
Decision
332d
Days
Class 2
Risk

K053524 is an FDA 510(k) clearance for the C-PORT DISTAL ANASTOMOSIS SYSTEM. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Cardica, Inc. (Redwood City, US). The FDA issued a Cleared decision on November 16, 2006 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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.

View all Cardica, Inc. devices

FDA 510(k) Submission Details - K053524

510(k) Number K053524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2005
Decision Date November 16, 2006
Days to Decision 332 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
217d slower than avg
Panel avg: 115d · This submission: 332d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZP Device Classification - Class 2, Special Controls

Product Code FZP Clip, Implantable
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.

Regulatory Peers - FZP Clip, Implantable

All 105
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K053524.
AESCULAP ENDOSCOPIC CLIP SYTEM
K080753 · Aesculap, Inc. · Apr 2008
AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
K071406 · United States Surgical, A Division of Tyco Healthc · Nov 2007
U-CLIP DEVICE
K062821 · Medtronic Neurosurgery · Dec 2006
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
K061288 · United States Surgical, A Division of Tyco Healthc · Nov 2006
HEM-O-LOK LIGATION CLIP
K062914 · Teleflex Medical · Nov 2006
U-CLIP DEVICE, MODEL NC65
K062057 · Medtronic Vascular · Aug 2006