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FDA 510(k)

Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload

K-Number: K161137 · 2016-07-20

ApplicantCardica, Inc.
Decision Date2016-07-20
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload is a medical device manufactured by Cardica, Inc.. It received FDA 510(k) clearance on 2016-07-20 under approval number K161137. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload?

Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload is a medical device that received FDA 510(k) clearance on 2016-07-20. It is manufactured by Cardica, Inc.. The 510(k) number is K161137.

When was Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload approved by the FDA?

Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload received FDA 510(k) clearance on 2016-07-20, under approval number K161137.

What company makes Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload?

Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload is manufactured by Cardica, Inc..

What is the FDA product code for Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload?

The FDA product code for Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload is GDW.

Other Devices by Cardica, Inc.

K151081MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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