Intimate Rose Vaginal Dilators— 510(k) K241748

Name: FDA 510(k) clearance K241748
Creator: U.S. Food and Drug Administration
Published: 2024-08-14

Substantially Equivalent

Plus EV Holdings Dba Intimate Rose

FDA 510(k) clearance K241748 for Intimate Rose Vaginal Dilators, Substantially Equivalent on 2024-08-14. Applicant: Plus EV Holdings Dba Intimate Rose. Device class: 2.

Clearance details

Applicant: Plus EV Holdings Dba Intimate Rose
Product code: Code HDX
Device class: Class 2
Regulation: 21 CFR 884.3900
Advisory panel: Obstetrics/Gynecology
Date received: 2024-06-18
Decision date: 2024-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HDX

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K233689 — Hope&Her Vaginal Dilators2024-05-02
K222492 — Hope&Her Vaginal Dilators2023-06-27
K231430 — Intimate Rose Vaginal Dilators2023-06-07
K220035 — Milli Vaginal Dilator2023-02-27
K211959 — Milli Vaginal Dilator2021-12-01

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K193364 — Intimate Rose Kegel Exercise System2020-08-24

Adverse events under product code HDX

product code HDX

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.