Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear 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 Endopath Ets-flex45 Endoscopic Articulating Linear Cutter, Endopath Ets-flex45 No-knife Articulating Linear Stapler.

Pre-market Notification Details

Device IDK150026
510k NumberK150026
Device Name:Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler
ClassificationStaple, Implantable
Applicant ETHICON ENDO-SURGERY, LLC 475 CALLE C Guaynabo,  PR 00969
ContactMarjorie Medina
CorrespondentChristina Canter
ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-07
Decision Date2015-05-18
Summary:summary

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