KARL STORZ Flexible HD Cysto-Urethroscope System

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 Karl Storz Flexible Hd Cysto-urethroscope System.

Pre-market Notification Details

Device IDK212476
510k NumberK212476
Device Name:KARL STORZ Flexible HD Cysto-Urethroscope System
ClassificationCystoscope And Accessories, Flexible/rigid
Applicant KARL STORZ Endoscopy America, Inc. 2151 E. Grand Ave El Segundo,  CA  90245
ContactWinkie Wong
CorrespondentThomas Ostrowski
KARL STORZ Endoscopy America, Inc. 2151 E. Grand Ave El Segundo,  CA  90245
Product CodeFAJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-06
Decision Date2021-09-03

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