FDA 510(k)

AUTO SUTURE* ABBI* SYSTEM

K-Number: K963825 · 1996-12-20

ApplicantUnited States Surgical, A Division of Tyco Healthc

Decision Date1996-12-20

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE* ABBI* 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 1996-12-20 under 510(k) number K963825. 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 AUTO SUTURE* ABBI* SYSTEM?

AUTO SUTURE* ABBI* SYSTEM is a medical device that received FDA 510(k) clearance on 1996-12-20. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K963825.

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

AUTO SUTURE* ABBI* SYSTEM received FDA 510(k) clearance on 1996-12-20, under 510(k) number K963825.

Who is the listed applicant for AUTO SUTURE* ABBI* 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 AUTO SUTURE* ABBI* SYSTEM?

The FDA product code for AUTO SUTURE* ABBI* 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.