CrossGlide ETS Plus

Curette, Suction, Endometrial (and Accessories)

CrossBay Medical

The following data is part of a premarket notification filed by Crossbay Medical with the FDA for Crossglide Ets Plus.

Pre-market Notification Details

Device IDK201952
510k NumberK201952
Device Name:CrossGlide ETS Plus
ClassificationCurette, Suction, Endometrial (and Accessories)
Applicant CrossBay Medical 13240 Evening Creek Drive, Suite 304 San Diego,  CA  92128
ContactPiush Vidyarthi
CorrespondentCindy Domecus
Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough,  CA  94010
Product CodeHHK  
CFR Regulation Number884.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-14
Decision Date2020-08-05

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