AUTO SUTURE SURGIPORT SPIRAL SLEEVE

Trocar, Gastro-urology

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 Surgiport Spiral Sleeve.

Pre-market Notification Details

Device IDK900123
510k NumberK900123
Device Name:AUTO SUTURE SURGIPORT SPIRAL SLEEVE
ClassificationTrocar, Gastro-urology
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
ContactCurtis Raymond
CorrespondentCurtis Raymond
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
Product CodeFBQ  
CFR Regulation Number876.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-09
Decision Date1990-04-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521099456 K900123 000
10884521099449 K900123 000
10884521099432 K900123 000
10884521099425 K900123 000
10884521099418 K900123 000
10884521099111 K900123 000

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