Cleared Special

K091017 - CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001

K091017 is an FDA 510(k) clearance for CARDICA PAS-PORT PROXIMAL ANASTOMOSIS S..., 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 20-day FDA review.

K091017 · Cardica, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
20d
Days
Class 2
Risk

K091017 is an FDA 510(k) clearance for the CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001. 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 April 29, 2009 after a review of 20 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 - K091017

510(k) Number K091017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2009
Decision Date April 29, 2009
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
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 K091017.
AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER
K100242 · Surgical Devices, A Division of Tyco Healthcare · Feb 2010
IMPLANTABLE CLIP
K100090 · Genicon · Feb 2010
VESOCCLUDE LIGATING CLIP
K091060 · Vesocclude Medical, LLC · Sep 2009
MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
K090872 · Cardica, Inc. · Apr 2009
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
K081225 · Cardica, Inc. · Sep 2008
U-CLIP UNI-FIRE, MODEL M65
K081082 · Medtronic, Inc. · May 2008