HARMONIC HD 1000i Shears, 20 Cm Length, HARMONIC HD 1000i Shears, 36 Cm Length

Instrument, Ultrasonic Surgical

Ethicon Endo-Surgery, LLC

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Harmonic Hd 1000i Shears, 20 Cm Length, Harmonic Hd 1000i Shears, 36 Cm Length.

Pre-market Notification Details

Device IDK191555
510k NumberK191555
Device Name:HARMONIC HD 1000i Shears, 20 Cm Length, HARMONIC HD 1000i Shears, 36 Cm Length
ClassificationInstrument, Ultrasonic Surgical
Applicant Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo,  PR  00969
ContactNathan Anderson
CorrespondentBrian Godwin
Ethicon Endo-Surgery, Inc. 4545 Creek Road, ML39 Cincinnati,  OH  45242
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical Specialty510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-12
Decision Date2020-02-28

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