510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211959Substantially Equivalent

Milli Vaginal Dilator

Materna Medical, Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211959 is the FDA 510(k) clearance record for Milli Vaginal Dilator, a class II device, cleared for Materna Medical on under FDA product code HDX (Dilator, Vaginal). FDA records list 2 510(k) clearances for Materna Medical, from to . As of , FDA records show no recalls naming K211959.

Clearance record

Decision date
Received
(160 days to decision)
Product code
HDX Dilator, Vaginal
Regulation
21 CFR 884.3900
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Materna Medical 2495 Hospital Dr., Suite 300, Mountain View CA
510(k) summary
Summary PDF
Third party review
No

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