FDA 510(k)

AUTO SUTURE* MODIFIED LINEAR STAPLER**

K-Number: K952239 · 1995-10-03

ApplicantUnited States Surgical, A Division of Tyco Healthc

Decision Date1995-10-03

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE* MODIFIED LINEAR STAPLER** 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 1995-10-03 under 510(k) number K952239. 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* MODIFIED LINEAR STAPLER**?

AUTO SUTURE* MODIFIED LINEAR STAPLER** is a medical device that received FDA 510(k) clearance on 1995-10-03. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K952239.

When did AUTO SUTURE* MODIFIED LINEAR STAPLER** receive FDA 510(k) clearance?

AUTO SUTURE* MODIFIED LINEAR STAPLER** received FDA 510(k) clearance on 1995-10-03, under 510(k) number K952239.

Who is the listed applicant for AUTO SUTURE* MODIFIED LINEAR STAPLER**?

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* MODIFIED LINEAR STAPLER**?

The FDA product code for AUTO SUTURE* MODIFIED LINEAR STAPLER** is GDW.

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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.