Mooncup, Style A & B
FDA 510(k)Class II (US FDA 510(k))
by Mooncup, LLC
Identifiers
- 510(k) Number
- K040335 FDA 510(k)
- FDA Product Code
- HHE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5400 FDA 510(k)
- Regulation Number
- 884.5400 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a menstrual cup, classified as Cup, Menstrual under regulation number 884.5400, with product code HHE and device class 2. It is substantially equivalent to a predicate device and was cleared via the traditional 510(k) pathway (K040335) on March 30, 2005, following receipt on February 11, 2004. The device is manufactured by Mooncup, LLC and is intended for use in the Obstetrics/Gynecology medical specialty.
The Mooncup, Style A & B remains entirely within the vagina during use, with the stem positioned outside the body to facilitate retrieval. It is supplied as a reusable device made from a soft silicone elastomer. The device is non-sterile and intended for repeated use after proper cleaning and care, as detailed in the manufacturer's instruction brochure. Storage and handling should follow the manufacturer's guidelines to maintain material integrity and safety.
Frequently asked questions
What is the MOONCUP, Style A & B intended for?
The MOONCUP, Style A & B is intended for use in the Obstetrics/Gynecology medical specialty as a menstrual cup that remains entirely within the vagina during use, with the stem positioned outside the body to facilitate retrieval.
Is the MOONCUP, Style A & B sterile or non-sterile, and is it single-use or reusable?
The device is supplied as a non-sterile, reusable device made from a soft silicone elastomer and is intended for repeated use after proper cleaning and care, as detailed in the manufacturer's instruction brochure.
How should the MOONCUP, Style A & B be stored and handled to maintain safety and integrity?
Storage and handling should follow the manufacturer's guidelines to maintain material integrity and safety, ensuring the silicone elastomer remains suitable for repeated use over time.
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. Sources consulted: MOONCUP, STYLE A & B (K040335) — FDA 510(k) | Innolitics, PDF MOONCUP, STYLE A & B 510(k) K040335 - FDA.report, Request and Purchase: FDA 510(k), K040335, MOONCUP, STYLE A & B
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040335 | Class II | Active |
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Manufacturer
- Manufacturer
- Mooncup, LLC
Sources (1)
- FDA 510(k) K040335 24 fields · synced Oct 6, 2026