CAPROSYN ABSORBABLE SUTURE

Suture, Absorbable, Synthetic, Polyglycolic Acid

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 Caprosyn Absorbable Suture.

Pre-market Notification Details

Device IDK032586
510k NumberK032586
Device Name:CAPROSYN ABSORBABLE SUTURE
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
ContactRobert Zott
CorrespondentRobert Zott
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-22
Decision Date2003-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521034621 K032586 000
20884521034409 K032586 000
20884521034355 K032586 000
20884521034348 K032586 000
20884521034331 K032586 000
20884521034324 K032586 000
20884521034317 K032586 000
20884521034300 K032586 000
20884521034294 K032586 000
20884521034287 K032586 000
20884521034263 K032586 000
20884521034256 K032586 000
20884521034249 K032586 000
20884521034232 K032586 000
20884521034225 K032586 000
20884521034140 K032586 000
20884521034102 K032586 000
30884523004094 K032586 000
20884523005469 K032586 000
20884521034577 K032586 000
20884521034560 K032586 000
20884521034553 K032586 000
20884521034546 K032586 000
20884521034430 K032586 000
20884521034423 K032586 000
20884521034416 K032586 000
20884521031569 K032586 000
20884523006046 K032586 000
20884523006015 K032586 000
20884523006008 K032586 000
20884523005995 K032586 000
20884523005520 K032586 000
20884523005513 K032586 000
20884523005506 K032586 000
20884523005483 K032586 000
20884521034010 K032586 000
20884521033983 K032586 000
20884521034041 K032586 000
20884521140810 K032586 000
20884521138718 K032586 000
20884521035567 K032586 000
20884521034607 K032586 000
20884521034454 K032586 000
20884521034195 K032586 000
20884521033679 K032586 000
20884521035437 K032586 000
20884521033723 K032586 000
20884521152226 K032586 000
20884521140827 K032586 000
20884521140773 K032586 000
20884521140780 K032586 000
20884521034676 K032586 000
20884521033945 K032586 000
20884521034447 K032586 000
20884521034614 K032586 000
20884521033969 K032586 000
20884521034270 K032586 000
20884521034218 K032586 000
20884521034201 K032586 000
20884521034171 K032586 000
20884521033716 K032586 000
30884523006036 K032586 000
20884523005490 K032586 000
20884523004073 K032586 000
20884521164069 K032586 000
20884521105680 K032586 000
20884521035130 K032586 000
20884521034591 K032586 000
20884521194820 K032586 000
20884521111346 K032586 000
20884521034638 K032586 000
20884521035543 K032586 000
10884521101708 K032586 000
20884521105413 K032586 000
20884521035529 K032586 000
20884521035505 K032586 000
20884521035482 K032586 000
20884521035185 K032586 000
20884521035178 K032586 000
20884521035161 K032586 000
20884521035154 K032586 000
20884521035147 K032586 000
20884521035116 K032586 000
20884521035109 K032586 000
20884521035093 K032586 000
20884521035086 K032586 000
20884521035079 K032586 000
20884521035062 K032586 000
20884521035031 K032586 000
20884521105611 K032586 000
20884521113555 K032586 000
20884521548623 K032586 000
20884521548616 K032586 000
20884521548609 K032586 000
20884521548593 K032586 000
20884521548586 K032586 000
20884521548579 K032586 000
20884521548562 K032586 000
20884521548555 K032586 000
20884521548524 K032586 000
20884521185941 K032586 000
20884521159799 K032586 000
20884521140834 K032586 000
20884521140797 K032586 000
20884521135465 K032586 000
20884521113814 K032586 000
20884521113579 K032586 000
20884521035024 K032586 000
20884521035017 K032586 000
20884521034829 K032586 000
20884521034812 K032586 000
20884521034805 K032586 000
20884521034799 K032586 000
20884521034782 K032586 000
20884521034775 K032586 000
20884521034768 K032586 000
20884521034751 K032586 000
20884521034744 K032586 000
20884521034737 K032586 000
20884521034720 K032586 000
20884521034713 K032586 000
20884521034706 K032586 000
20884521034690 K032586 000
20884521034669 K032586 000
20884521034652 K032586 000
20884521034836 K032586 000
20884521034843 K032586 000
20884521035000 K032586 000
20884521034997 K032586 000
20884521034980 K032586 000
20884521034973 K032586 000
20884521034966 K032586 000
20884521034959 K032586 000
20884521034942 K032586 000
20884521034935 K032586 000
20884521034928 K032586 000
20884521034911 K032586 000
20884521034904 K032586 000
20884521034898 K032586 000
20884521034881 K032586 000
20884521034874 K032586 000
20884521034867 K032586 000
20884521034850 K032586 000
20884521034645 K032586 000

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