KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE

Kit, Nephroscope

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 Adult & Pediatric Nephroscope.

Pre-market Notification Details

Device IDK940594
510k NumberK940594
Device Name:KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE
ClassificationKit, Nephroscope
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 CodeFGA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-09
Decision Date1994-09-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551366608 K940594 000
04048551350324 K940594 000
04048551348741 K940594 000
04048551347584 K940594 000
04048551426654 K940594 000
04048551366660 K940594 000
04048551072899 K940594 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.