RITA STARBURST XLI ELECTROSURGICAL DEVICE

Electrosurgical, Cutting & Coagulation & Accessories

RITA MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Rita Medical Systems with the FDA for Rita Starburst Xli Electrosurgical Device.

Pre-market Notification Details

Device IDK010060
510k NumberK010060
Device Name:RITA STARBURST XLI ELECTROSURGICAL DEVICE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant RITA MEDICAL SYSTEMS 967 NORTH SHORELINE BLVD. Mountain View,  CA  94043
ContactErin Mazzone
CorrespondentMichael Kwan
UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara,  CA  95050
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2001-01-08
Decision Date2001-01-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H7877001040771 K010060 000
H7877001030271 K010060 000
H7877001030241 K010060 000
H7877001028471 K010060 000
H7877001028461 K010060 000
H7877001028451 K010060 000

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