ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,

Electrosurgical, Cutting & Coagulation & Accessories

ETHICON ENDO-SURGERY, LLC

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Enseal G2 Tissue Sealer, Straight Jaw, Enseal G2 Tissue Sealer, Curved Jaw, Enseal Trio Tissue Sealer, 3 Mm Curved Jaw,.

Pre-market Notification Details

Device IDK131435
510k NumberK131435
Device Name:ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati,  OH  45242
ContactMarica Arentz
CorrespondentMarica Arentz
ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati,  OH  45242
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-20
Decision Date2013-10-03
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.