FLEXIBLE VIDEO-URETERO-RENOSCOPE 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-renoscope System.

Pre-market Notification Details

Device IDK141250
510k NumberK141250
Device Name:FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
ClassificationUreteroscope And Accessories, Flexible/rigid
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE El Segundo,  CA  90245
ContactLeigh Spotten
CorrespondentLeigh Spotten
KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE El Segundo,  CA  90245
Product CodeFGB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-14
Decision Date2014-06-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551416976 K141250 000
04048551416969 K141250 000
04048551402597 K141250 000
04048551344385 K141250 000
04048551334140 K141250 000

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