DeviceClearance

Product code HDX— Obstetrics/Gynecology

Hope&Her Vaginal Dilators

Classification name
Dilator, Vaginal
Device class
Class 2
Regulation
21 CFR 884.3900
Advisory panel
Obstetrics/Gynecology
Total cleared
9
First cleared
Most recent

Market context for product code HDX

FDA has cleared 9 devices under product code HDX between 2001 and 2024, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code HDX

Adverse events under product code HDX

product code HDX
Other
1
Total
1

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

Recent clearances under product code HDX

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