Class Class II

FemVue® Controlled Saline-Air Device (FSA-300) (K253403)

K253403 2025-12-15 Traditional
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Description

FemVue® Controlled Saline-Air Device (FSA-300) by Femasys, Inc., an FDA 510(k) cleared obstetrics/gynecology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK253403
Clearance Date2025-12-15
Clearance TypeTraditional
Product CodeLKF
Regulation Number884.4530

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