Pelvital USA, Inc. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)510(k)Aug 1, 2024Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Aug 1, 2024
Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)510(k)Dec 29, 2023Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Special)	Dec 29, 2023
Flyte510(k)Sep 21, 2021Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Special)	Sep 21, 2021
Flyte510(k)Apr 13, 2021Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Special)	Apr 13, 2021