FDA 510(k)

AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES

K-Number: K914130 · 1991-10-17

ApplicantUnited States Surgical, A Division of Tyco Healthc

Decision Date1991-10-17

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1991-10-17 under 510(k) number K914130. 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 AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES?

AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES is a medical device that received FDA 510(k) clearance on 1991-10-17. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K914130.

When did AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES receive FDA 510(k) clearance?

AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES received FDA 510(k) clearance on 1991-10-17, under 510(k) number K914130.

Who is the listed applicant for AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES?

The FDA product code for AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES 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.