FDA 510(k)

AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY

K-Number: K093410 · 2009-11-12

ApplicantSurgical Devices, A Divsion of Tyco Healthcare

Decision Date2009-11-12

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Devices, A Divsion of Tyco Healthcare. It received FDA 510(k) clearance on 2009-11-12 under 510(k) number K093410. 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 AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY?

AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY is a medical device that received FDA 510(k) clearance on 2009-11-12. The listed applicant is Surgical Devices, A Divsion of Tyco Healthcare. The 510(k) number is K093410.

When did AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY receive FDA 510(k) clearance?

AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY received FDA 510(k) clearance on 2009-11-12, under 510(k) number K093410.

Who is the listed applicant for AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY?

The FDA 510(k) record lists Surgical Devices, A Divsion of Tyco Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY?

The FDA product code for AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY is GDW.

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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.