FDA 510(k)

SURGICAL STAPLE

K-Number: K942606 · 1994-08-24

ApplicantUnited States Surgical, A Division of Tyco Healthc

Decision Date1994-08-24

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SURGICAL STAPLE 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 1994-08-24 under 510(k) number K942606. 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 SURGICAL STAPLE?

SURGICAL STAPLE is a medical device that received FDA 510(k) clearance on 1994-08-24. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K942606.

When did SURGICAL STAPLE receive FDA 510(k) clearance?

SURGICAL STAPLE received FDA 510(k) clearance on 1994-08-24, under 510(k) number K942606.

Who is the listed applicant for SURGICAL STAPLE?

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 SURGICAL STAPLE?

The FDA product code for SURGICAL STAPLE 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.