ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED

Staple, Implantable

ETHICON ENDO-SURGERY, INC.

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Echelon Flex Powered Vascular Stapler With Advanced Placement Tip, Endopath Echelon Vascular White Reloads For Advanced.

Pre-market Notification Details

Device IDK141952
510k NumberK141952
Device Name:ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
ClassificationStaple, Implantable
Applicant ETHICON ENDO-SURGERY, INC. 4545 CREEK ROAD Cincinnati,  OH  45242
ContactLinda Hill
CorrespondentLinda Hill
ETHICON ENDO-SURGERY, INC. 4545 CREEK ROAD Cincinnati,  OH  45242
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-18
Decision Date2014-11-24
Summary:summary

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