KSEA NEUROENDOSCOPES AND ACCESSORIES

Endoscope, Neurological

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 Ksea Neuroendoscopes And Accessories.

Pre-market Notification Details

Device IDK021050
510k NumberK021050
Device Name:KSEA NEUROENDOSCOPES AND ACCESSORIES
ClassificationEndoscope, Neurological
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactJames A Lee
CorrespondentJames A Lee
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-01
Decision Date2002-06-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551288825 K021050 000
04048551097724 K021050 000
04048551097748 K021050 000
04048551097823 K021050 000
04048551097861 K021050 000
04048551097908 K021050 000
04048551097922 K021050 000
04048551097977 K021050 000
04048551098240 K021050 000
04048551098325 K021050 000
04048551097762 K021050 000
04048551097953 K021050 000
04048551191439 K021050 000
04048551288788 K021050 000
04048551288795 K021050 000
04048551288801 K021050 000
04048551097694 K021050 000

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