ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 Cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 Cm Shaft Length

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 X1 Tissue Sealer, Curved Jaw, Articulating 37 Cm Shaft Length; Enseal X1 Tissue Sealer, Curved Jaw, Articulating 45 Cm Shaft Length.

Pre-market Notification Details

Device IDK180403
510k NumberK180403
Device Name:ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 Cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 Cm Shaft Length
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo,  PR  00969
ContactSigfrido Delgado
CorrespondentKweku Biney
Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati,  OH  45242
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-14
Decision Date2018-05-23
Summary:summary

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