Cleared Special

K070548 - C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM

K070548 is an FDA 510(k) clearance for C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM, manufactured by Cardica, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Special 510(k) pathway after a 31-day FDA review.

K070548 · Cardica, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
31d
Days
Class 2
Risk

K070548 is an FDA 510(k) clearance for the C-PORT FLEXA 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 March 29, 2007 after a review of 31 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070548

510(k) Number K070548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2007
Decision Date March 29, 2007
Days to Decision 31 days
Submission Type Special
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
84d faster than avg
Panel avg: 115d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

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 173
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K070548.
CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150
K073123 · Cardica, Inc. · Dec 2007
AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
K071406 · United States Surgical, A Division of Tyco Healthc · Nov 2007
ZIPKNOT, MODEL 1017-3000
K072525 · Medicinelodge, Inc. · Oct 2007
CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
K063644 · Cardica, Inc. · Jan 2007
U-CLIP DEVICE
K062821 · Medtronic Neurosurgery · Dec 2006
C-PORT DISTAL ANASTOMOSIS SYSTEM
K053524 · Cardica, Inc. · Nov 2006