FDA 510(k)

THE AUTO SUTURE* MIBB** SYSTEM

K-Number: K973496 · 1997-12-01

ApplicantUnited States Surgical, A Division of Tyco Healthc

Decision Date1997-12-01

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

THE AUTO SUTURE* MIBB** SYSTEM 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 1997-12-01 under 510(k) number K973496. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE AUTO SUTURE* MIBB** SYSTEM?

THE AUTO SUTURE* MIBB** SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-01. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K973496.

When did THE AUTO SUTURE* MIBB** SYSTEM receive FDA 510(k) clearance?

THE AUTO SUTURE* MIBB** SYSTEM received FDA 510(k) clearance on 1997-12-01, under 510(k) number K973496.

Who is the listed applicant for THE AUTO SUTURE* MIBB** SYSTEM?

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 THE AUTO SUTURE* MIBB** SYSTEM?

The FDA product code for THE AUTO SUTURE* MIBB** SYSTEM is KNW.

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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.