ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

ETHICON ENDO-SURGERY, INC.

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endo Window High Frequency Electrocautery Device, Model Ew018.

Pre-market Notification Details

Device IDK021266
510k NumberK021266
Device Name:ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
ContactKen Charak
CorrespondentKen Charak
ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-22
Decision Date2002-09-27
Summary:summary

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