KSEA SPINOSCOPE

Arthroscope

KARL STORZ ENDOSCOPY

The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Ksea Spinoscope.

Pre-market Notification Details

Device IDK023187
510k NumberK023187
Device Name:KSEA SPINOSCOPE
ClassificationArthroscope
Applicant KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactJames A Lee
CorrespondentJames A Lee
KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-24
Decision Date2002-12-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551405154 K023187 000

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