ECHELON CIRCULAR Powered Stapler

Staple, Implantable

Ethicon Endo-Surgery, LLC

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Echelon Circular Powered Stapler.

Pre-market Notification Details

Device IDK163523
510k NumberK163523
Device Name:ECHELON CIRCULAR Powered Stapler
ClassificationStaple, Implantable
Applicant Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo,  PR  00969
ContactCarmen Ortiz
CorrespondentRubina Dosani
Ethicon Endo-Surgery, LLC 4545 Creek Road Cincinnati,  OH  45242
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-15
Decision Date2017-04-18
Summary:summary

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