Flexible Video Cysto-Urethroscope (C-view)

Cystoscope And Accessories, Flexible/rigid

KARL STORZ Endoscopy-America, Inc

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc with the FDA for Flexible Video Cysto-urethroscope (c-view).

Pre-market Notification Details

Device IDK202957
510k NumberK202957
Device Name:Flexible Video Cysto-Urethroscope (C-view)
ClassificationCystoscope And Accessories, Flexible/rigid
Applicant KARL STORZ Endoscopy-America, Inc 2151 E. Grand Avenue Ei Segundo,  CA  90245
ContactWinkie Wong
CorrespondentWinkie Wong
KARL STORZ Endoscopy-America, Inc 2151 E. Grand Avenue Ei Segundo,  CA  90245
Product CodeFAJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-30
Decision Date2020-10-29

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