ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK

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 Endoscopic Linear Cutter Reload, Black.

Pre-market Notification Details

Device IDK131663
510k NumberK131663
Device Name:ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK
ClassificationStaple, Implantable
Applicant ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati,  OH  45242
ContactChristina Canter
CorrespondentChristina Canter
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 Received2013-06-07
Decision Date2013-10-18
Summary:summary

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