FLEXIBLE ENDOSCOPIC ELECTRODE

Electrode, Electrosurgical, Active, Urological

APPLIED UROLOGY, INC.

The following data is part of a premarket notification filed by Applied Urology, Inc. with the FDA for Flexible Endoscopic Electrode.

Pre-market Notification Details

Device IDK905731
510k NumberK905731
Device Name:FLEXIBLE ENDOSCOPIC ELECTRODE
ClassificationElectrode, Electrosurgical, Active, Urological
Applicant APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills,  CA  92653
ContactJo Stegwell
CorrespondentJo Stegwell
APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills,  CA  92653
Product CodeFAS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-24
Decision Date1991-01-31

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