FEMVUE CORNUAL BALLOON CATHETER

Cannula, Manipulator/injector, Uterine

FEMASYS INC.

The following data is part of a premarket notification filed by Femasys Inc. with the FDA for Femvue Cornual Balloon Catheter.

Pre-market Notification Details

Device IDK100662
510k NumberK100662
Device Name:FEMVUE CORNUAL BALLOON CATHETER
ClassificationCannula, Manipulator/injector, Uterine
Applicant FEMASYS INC. 5000 RESEARCH COURT STE .100 Suwanee,  GA  30024
ContactLisa Peacock
CorrespondentLisa Peacock
FEMASYS INC. 5000 RESEARCH COURT STE .100 Suwanee,  GA  30024
Product CodeLKF  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-08
Decision Date2010-04-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00859500005035 K100662 000
00859500005080 K100662 000
00859500005042 K100662 000

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