AUTO SUTURE TITANIUM SURGICAL STAPLES

Staple, Implantable

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 Titanium Surgical Staples.

Pre-market Notification Details

Device IDK855047
510k NumberK855047
Device Name:AUTO SUTURE TITANIUM SURGICAL STAPLES
ClassificationStaple, Implantable
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
ContactWalter S Henning
CorrespondentWalter S Henning
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-17
Decision Date1986-01-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521047379 K855047 000
20884521047706 K855047 000
20884521047713 K855047 000
20884521047720 K855047 000
20884521047737 K855047 000
20884521047331 K855047 000
20884521047355 K855047 000
20884521047362 K855047 000
20884521047386 K855047 000
20884521047409 K855047 000
20884521047423 K855047 000
20884521047430 K855047 000
20884521047447 K855047 000
20884521047690 K855047 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.