Flexible Video-Uretero-Choledochoscope System

Ureteroscope 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-uretero-choledochoscope System.

Pre-market Notification Details

Device IDK142556
510k NumberK142556
Device Name:Flexible Video-Uretero-Choledochoscope System
ClassificationUreteroscope And Accessories, Flexible/rigid
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE El Segundo,  CA  90245
ContactMike Samuels
CorrespondentMike Samuels
KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE El Segundo,  CA  90245
Product CodeFGB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-11
Decision Date2014-10-23
Summary:summary

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