ENDOPATH ENDOSCOPIC INSTRUMENTS

Electrosurgical, Cutting & Coagulation & Accessories

ETHICON ENDO-SURGERY, INC.

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

Pre-market Notification Details

Device IDK984240
510k NumberK984240
Device Name:ENDOPATH ENDOSCOPIC INSTRUMENTS
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
ContactJackie A Strasser
CorrespondentJackie A Strasser
ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-27
Decision Date1999-06-22
Summary:summary

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