AUTO SUTURE SURGIWAND

Electrosurgical, Cutting & Coagulation & Accessories

UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Auto Suture Surgiwand.

Pre-market Notification Details

Device IDK961771
510k NumberK961771
Device Name:AUTO SUTURE SURGIWAND
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
ContactVictor Clavelli
CorrespondentVictor Clavelli
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-08
Decision Date1996-09-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884523000983 K961771 000
20884523000938 K961771 000
20884523000921 K961771 000
20884523000914 K961771 000
20884523000907 K961771 000
20884523000891 K961771 000
20884523000884 K961771 000
20884523000877 K961771 000
20884523000860 K961771 000

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