Intimate Rose Vaginal Dilators
K-Number: K231430 · 2023-06-07
ApplicantPlus EV Holdings Dba Intimate Rose
Decision Date2023-06-07
Product CodeHDX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Intimate Rose Vaginal Dilators is a medical device manufactured by Plus EV Holdings Dba Intimate Rose. It received FDA 510(k) clearance on 2023-06-07 under approval number K231430. The device is classified under product code HDX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Intimate Rose Vaginal Dilators?
Intimate Rose Vaginal Dilators is a medical device that received FDA 510(k) clearance on 2023-06-07. It is manufactured by Plus EV Holdings Dba Intimate Rose. The 510(k) number is K231430.
When was Intimate Rose Vaginal Dilators approved by the FDA?
Intimate Rose Vaginal Dilators received FDA 510(k) clearance on 2023-06-07, under approval number K231430.
What company makes Intimate Rose Vaginal Dilators?
Intimate Rose Vaginal Dilators is manufactured by Plus EV Holdings Dba Intimate Rose.
What is the FDA product code for Intimate Rose Vaginal Dilators?
The FDA product code for Intimate Rose Vaginal Dilators is HDX.
Other Devices by Plus EV Holdings Dba Intimate Rose
Related Devices (Code: HDX)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.