HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE

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 Ace Curved Shears With Ergonomic Handle.

Pre-market Notification Details

Device IDK132522
510k NumberK132522
Device Name:HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
ClassificationInstrument, Ultrasonic Surgical
Applicant ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati,  OH  45242
ContactDavid Locke
CorrespondentDavid Locke
ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati,  OH  45242
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-12
Decision Date2013-12-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30705036000970 K132522 000

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