KARL STORZ URETERO-RENOSCOPE/URETERSCOPE

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 Karl Storz Uretero-renoscope/ureterscope.

Pre-market Notification Details

Device IDK940464
510k NumberK940464
Device Name:KARL STORZ URETERO-RENOSCOPE/URETERSCOPE
ClassificationUreteroscope And Accessories, Flexible/rigid
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington,  DC  20004 -1109
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
KARL STORZ ENDOSCOPY-AMERICA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington,  DC  20004 -1109
Product CodeFGB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-02
Decision Date1994-06-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551347317 K940464 000
04048551232071 K940464 000
04048551405307 K940464 000
04048551405314 K940464 000
04048551405451 K940464 000
04048551405468 K940464 000
04048551347249 K940464 000
04048551347263 K940464 000
04048551347287 K940464 000
04048551426692 K940464 000
04048551231333 K940464 000

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