TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))

Laparoscope, Gynecologic (and Accessories)

Schoelly Fiberoptic GmbH

The following data is part of a premarket notification filed by Schoelly Fiberoptic Gmbh with the FDA for Tipvision Videoscope System (tipvision Videoscope 0°/30°; Elevision Hd 2 Camera Control Unit (ccu)).

Pre-market Notification Details

Device IDK201617
510k NumberK201617
Device Name:TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant Schoelly Fiberoptic GmbH Robert-Bosch-Strasse 1-3 Denzlingen,  DE 79211
ContactSandra Baumann
CorrespondentPamela Papineau
Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer,  MA  01432
Product CodeHET  
Subsequent Product CodeFET
Subsequent Product CodeGCJ
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-15
Decision Date2021-03-12

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