Endomat Select, IBS Shaver Software, License

Insufflator, Hysteroscopic

Karl Storz SE & Co. KG

The following data is part of a premarket notification filed by Karl Storz Se & Co. Kg with the FDA for Endomat Select, Ibs Shaver Software, License.

Pre-market Notification Details

Device IDK201355
510k NumberK201355
Device Name:Endomat Select, IBS Shaver Software, License
ClassificationInsufflator, Hysteroscopic
Applicant Karl Storz SE & Co. KG Dr.-Karl-Storz-Strasse 34 Tuttlingen,  DE 78532
ContactAlexey Davidov
CorrespondentAlexey Davidov
Karl Storz SE & Co. KG Dr.-Karl-Storz-Strasse 34 Tuttlingen,  DE 78532
Product CodeHIG  
Subsequent Product CodeBTA
Subsequent Product CodeGWG
Subsequent Product CodeHRX
Subsequent Product CodeLJH
Subsequent Product CodeOCX
CFR Regulation Number884.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-21
Decision Date2020-07-22

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