PhotonBlade With Smoke Evacuation

Electrosurgical, Cutting & Coagulation & Accessories

Invuity Inc.

The following data is part of a premarket notification filed by Invuity Inc. with the FDA for Photonblade With Smoke Evacuation.

Pre-market Notification Details

Device IDK191583
510k NumberK191583
Device Name:PhotonBlade With Smoke Evacuation
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Invuity Inc. 444 De Haro Street San Francisco,  CA  94107
ContactDione Fuller
CorrespondentSusanne Galin
Invuity Inc. 444 De Haro Street San Francisco,  CA  94107
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-14
Decision Date2020-03-06

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