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FDA 510(k)

Milli Vaginal Dilator

K-Number: K220035 · 2023-02-27

ApplicantMaterna Medical
Decision Date2023-02-27
Product CodeHDX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Milli Vaginal Dilator is the device name listed in this FDA 510(k) record. The listed applicant is Materna Medical. It received FDA 510(k) clearance on 2023-02-27 under 510(k) number K220035. 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 2023-02-27. The listed applicant is Materna Medical. The 510(k) number is K220035.

When did Milli Vaginal Dilator receive FDA 510(k) clearance?

Milli Vaginal Dilator received FDA 510(k) clearance on 2023-02-27, under 510(k) number K220035.

Who is the listed applicant for Milli Vaginal Dilator?

The FDA 510(k) record lists Materna Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Milli Vaginal Dilator?

The FDA product code for Milli Vaginal Dilator is HDX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03973281EASE: The Materna Prep Pivotal StudyCOMPLETED

Other records listing Materna Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211959Milli Vaginal Dilator

Related Devices (Code: HDX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241748Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate RoseK233689Hope&Her Vaginal DilatorsLujena, Inc.K222492Hope&Her Vaginal DilatorsLujena, Inc.K231430Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate RoseK211959Milli Vaginal DilatorMaterna Medical

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.

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