ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER

Endoscopic Tissue Approximation Device

ETHICON ENDO-SURGERY, INC.

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Ez45 Endoscopic Linear Cutter.

Pre-market Notification Details

Device IDK980815
510k NumberK980815
Device Name:ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER
ClassificationEndoscopic Tissue Approximation Device
Applicant ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
ContactLorri Chavez
CorrespondentLorri Chavez
ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
Product CodeOCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-03
Decision Date1998-05-01
Summary:summary

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