TIPCAM 1S 3D System

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 Tipcam 1s 3d System.

Pre-market Notification Details

Device IDK162880
510k NumberK162880
Device Name:TIPCAM 1S 3D System
ClassificationEndoscope, Neurological
Applicant KARL STORZ Endoscopy America, Inc 2151 E. Grand Avenue El Segundo,  CA  90245
ContactWinkie Wong
CorrespondentWinkie Wong
KARL STORZ Endoscopy America, Inc 2151 E. Grand Avenue El Segundo,  CA  90245
Product CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-14
Decision Date2017-03-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551422625 K162880 000
04048551416174 K162880 000
04048551396018 K162880 000
04048551396001 K162880 000

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