Harmonic 1100 Shears, 20cm Length, Harmonic 1100 36cm Length, Generator G11

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 Harmonic 1100 Shears, 20cm Length, Harmonic 1100 36cm Length, Generator G11.

Pre-market Notification Details

Device IDK200841
510k NumberK200841
Device Name:Harmonic 1100 Shears, 20cm Length, Harmonic 1100 36cm Length, Generator G11
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Ethicon Endo-Surgery, Llc 475 Calle C Guaynabo,  PR  00969
ContactNathan Anderson
CorrespondentBrian Godwin
Ethicon Endo-Surgery, Inc 4545 Creek Rd Cincinnati,  OH  45242
Product CodeGEI  
Subsequent Product CodeHGI
Subsequent Product CodeLFL
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-31
Decision Date2020-05-11

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