ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505

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 Ethicon Endo-surgery Articulating Hook Knife, Model In4505.

Pre-market Notification Details

Device IDK082955
510k NumberK082955
Device Name:ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
ContactGlenda C Marsh
CorrespondentGlenda C Marsh
ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-03
Decision Date2009-01-15
Summary:summary

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