FDA 510(k)

AUTO SUTURE CHEMOSITE TUNNELER

K-Number: K961856 · 1996-07-18

ApplicantUnited States Surgical, A Division of Tyco Healthc

Decision Date1996-07-18

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE CHEMOSITE TUNNELER 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 1996-07-18 under 510(k) number K961856. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SUTURE CHEMOSITE TUNNELER?

AUTO SUTURE CHEMOSITE TUNNELER is a medical device that received FDA 510(k) clearance on 1996-07-18. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K961856.

When did AUTO SUTURE CHEMOSITE TUNNELER receive FDA 510(k) clearance?

AUTO SUTURE CHEMOSITE TUNNELER received FDA 510(k) clearance on 1996-07-18, under 510(k) number K961856.

Who is the listed applicant for AUTO SUTURE CHEMOSITE TUNNELER?

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 CHEMOSITE TUNNELER?

The FDA product code for AUTO SUTURE CHEMOSITE TUNNELER is LJS.

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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.