FDA 510(k)

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

K-Number: K151081 · 2016-01-15

Decision Date2016-01-15

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Cardica, Inc.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K151081. 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 MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge?

MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Cardica, Inc.. The 510(k) number is K151081.

When did MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge receive FDA 510(k) clearance?

MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge received FDA 510(k) clearance on 2016-01-15, under 510(k) number K151081.

Who is the listed applicant for MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge?

The FDA 510(k) record lists Cardica, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge?

The FDA product code for MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge is GDW.

Other records listing Cardica, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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