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FDA 510(k)

Intimate Rose Vaginal Dilators

K-Number: K241748 · 2024-08-14

ApplicantPlus EV Holdings Dba Intimate Rose
Decision Date2024-08-14
Product CodeHDX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Intimate Rose Vaginal Dilators is the device name listed in this FDA 510(k) record. The listed applicant is Plus EV Holdings Dba Intimate Rose. It received FDA 510(k) clearance on 2024-08-14 under 510(k) number K241748. 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 2024-08-14. The listed applicant is Plus EV Holdings Dba Intimate Rose. The 510(k) number is K241748.

When did Intimate Rose Vaginal Dilators receive FDA 510(k) clearance?

Intimate Rose Vaginal Dilators received FDA 510(k) clearance on 2024-08-14, under 510(k) number K241748.

Who is the listed applicant for Intimate Rose Vaginal Dilators?

The FDA 510(k) record lists Plus EV Holdings Dba Intimate Rose as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intimate Rose Vaginal Dilators?

The FDA product code for Intimate Rose Vaginal Dilators is HDX.

Other records listing Plus EV Holdings Dba Intimate Rose 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.

K231430Intimate Rose Vaginal DilatorsK193364Intimate Rose Kegel Exercise System

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.

K233689Hope&Her Vaginal DilatorsLujena, Inc.K222492Hope&Her Vaginal DilatorsLujena, Inc.K231430Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate RoseK220035Milli Vaginal DilatorMaterna MedicalK211959Milli 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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