URETHRAL ELECTRODE SHEATH

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 Urethral Electrode Sheath.

Pre-market Notification Details

Device IDK915219
510k NumberK915219
Device Name:URETHRAL ELECTRODE SHEATH
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 Received1991-11-20
Decision Date1992-07-23

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