Identifiers
- 510(k) Number
- K220035 FDA 510(k)
- FDA Product Code
- HDX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.3900 FDA 510(k)
- Regulation Number
- 884.3900 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Milli Vaginal Dilator is a Class II medical device designed for vaginal dilation. It is intended for use in obstetrics and gynecology settings to help with vaginal dilation procedures.
The Milli Vaginal Dilator is supplied as a single-use device and requires proper storage conditions. It has received FDA 510(k) clearance with the product code HDX and is regulated under 884.3900.
Frequently asked questions
What is the Milli Vaginal Dilator used for?
The Milli Vaginal Dilator is a Class II medical device designed for vaginal dilation procedures in obstetrics and gynecology settings. It helps healthcare professionals perform dilation procedures effectively and safely.
Is the Milli Vaginal Dilator single-use or reusable?
The Milli Vaginal Dilator is supplied as a single-use device, meaning it should be used for one patient only and then properly disposed of according to medical waste guidelines to ensure safety and prevent cross-contamination.
What regulatory approvals does the Milli Vaginal Dilator have?
The Milli Vaginal Dilator has received FDA 510(k) clearance with product code HDX and is regulated under 884.3900. It was determined to be substantially equivalent to other devices in its class through the traditional clearance process.
How should the Milli Vaginal Dilator be stored?
The Milli Vaginal Dilator requires proper storage conditions to maintain its integrity and functionality. It should be stored in a clean, dry environment at room temperature, away from direct sunlight and extreme temperatures, as specified by the manufacturer.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220035 | Class II | Active |
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Manufacturer
- Manufacturer
- Materna Medical
Sources (1)
- FDA 510(k) K220035 24 fields · synced Sep 21, 2026