KARL STORZ ShuntScope

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 Karl Storz Shuntscope.

Pre-market Notification Details

Device IDK170462
510k NumberK170462
Device Name:KARL STORZ ShuntScope
ClassificationEndoscope, Neurological
Applicant KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue Ei Segundo,  CA  90245
ContactSusie S. Chen
CorrespondentNozomi S. Yagi
KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue Ei Segundo,  CA  90245
Product CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-15
Decision Date2017-05-16
Summary:summary

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