FDA 510(k)

Milli Vaginal Dilator

K-Number: K211959 · 2021-12-01

Decision Date2021-12-01

Product CodeHDX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Milli Vaginal Dilator is a medical device manufactured by Materna Medical. It received FDA 510(k) clearance on 2021-12-01 under approval number K211959. 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 Milli Vaginal Dilator?

Milli Vaginal Dilator is a medical device that received FDA 510(k) clearance on 2021-12-01. It is manufactured by Materna Medical. The 510(k) number is K211959.

When was Milli Vaginal Dilator approved by the FDA?

Milli Vaginal Dilator received FDA 510(k) clearance on 2021-12-01, under approval number K211959.

What company makes Milli Vaginal Dilator?

Milli Vaginal Dilator is manufactured by Materna Medical.

What is the FDA product code for Milli Vaginal Dilator?

The FDA product code for Milli Vaginal Dilator is HDX.

Related Clinical Trials

NCT07038512 Evaluation of Hyivy Floora in Managing Interstitial Cystitis/Bladder Pain Syndrome/High-tone Pelvic Floor Dysfunction NOT_YET_RECRUITING

Other Devices by Materna Medical

K220035Milli Vaginal Dilator

Related Devices (Code: HDX)

K222492Hope&Her Vaginal DilatorsLujena, Inc. K231430Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose K220035Milli Vaginal DilatorMaterna Medical K241748Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose K233689Hope&Her Vaginal DilatorsLujena, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.