510(k) Report

FDA applicant

Cardica, Inc.

Redwood City, CA15 decisions2005–20164 recalls

FDA records 15 decisions for Cardica, Inc. (Redwood City, CA) from 2005 to 2016: 15 510(k) clearances. Most are in product codes FZP (Clip, Implantable) and GDW (Staple, Implantable). Its devices cite 25 predicates, 16 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Cardica, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2007: 42008: 12009: 22010: 12014: 32016: 2
2007high 4 (2007) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

2in 2018

2015: 22018: 2
2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cardica, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardica, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FZPClip, Implantable10decisions
  • GDWStaple, Implantable5decisions

Whose devices does it build on?

Its devices cite 25 predicates; 16 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 16 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K063644Cardica C-Port XA Distal Anastomosis SystemCardica, Inc. · 20073cite it
  • K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple CartridgeCardica, Inc. · 20143cite it
  • K040832C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050Cardica, Inc. · 20052cite it
  • K053524C-Port Distal Anastomosis SystemCardica, Inc. · 20062cite it
  • K151081MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White CartridgeCardica, Inc. · 20161cites it
  • K090872Modification to Cardica C-Port XA Distal Anastomosis SystemCardica, Inc. · 20091cites it

What has FDA decided for it lately?

  • K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc. · 2016
  • K151081MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White CartridgeCardica, Inc. · 2016
  • K140118Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeCardica, Inc. · 20142 recalls
  • K140170Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc. · 20142 recalls
  • K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple CartridgeCardica, Inc. · 20141 recall
  • K101018Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100Cardica, Inc. · 20101 recall
  • K091017Cardica Pas-Port Proximal Anastomosis System, Model FG-000001Cardica, Inc. · 2009
  • K090872Modification to Cardica C-Port XA Distal Anastomosis SystemCardica, Inc. · 20091 recall

All 15 as Cardica, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K090872AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The…Apr 2, 2018Class II
  • K070548AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number…Apr 2, 2018Class II
  • K140118MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The…Nov 6, 2015Class II
  • K132581MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue…Nov 6, 2015Class II