510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231430Substantially Equivalent

Intimate Rose Vaginal Dilators

Plus EV Holdings dba Intimate Rose, North Kansas City MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231430 is the FDA 510(k) clearance record for Intimate Rose Vaginal Dilators, a class II device, cleared for Plus EV Holdings Dba Intimate Rose on under FDA product code HDX (Dilator, Vaginal). FDA records list 3 510(k) clearances for Plus EV Holdings Dba Intimate Rose, from to . As of , FDA records show no recalls naming K231430.

Clearance record

Decision date
Received
(21 days to decision)
Product code
HDX Dilator, Vaginal
Regulation
21 CFR 884.3900
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Plus EV Holdings Dba Intimate Rose 1419 Murray St., North Kansas City MO
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code HDX

Trailing 12 months

FDA records hold no clearances under product code HDX in the trailing twelve months.

FDA records show no clearances under product code HDX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HDX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260