MOONCUP
Device Facts
| Record ID | K060852 |
|---|---|
| Device Name | MOONCUP |
| Applicant | Mooncup Limited |
| Product Code | HHE · Obstetrics/Gynecology |
| Decision Date | Dec 26, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5400 |
| Device Class | Class 2 |
Indications for Use
The Mooncup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
Device Story
Mooncup is a menstrual cup; device is a receptacle inserted into the vagina to collect menstrual blood and cellular debris extruded from the uterus. Designed for over-the-counter use by menstruating individuals. Device functions as a passive collection vessel; no active components, sensors, or software. User inserts device manually; removes for emptying and cleaning. Provides a reusable alternative to traditional absorbent menstrual products.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Device is a menstrual cup; form factor is a flexible, bell-shaped receptacle. Materials are medical-grade silicone. Device is non-powered, passive, and reusable. No software or electronic components.
Indications for Use
Indicated for use by menstruating individuals as a vaginal receptacle to collect menstrual fluid and cellular debris.
Regulatory Classification
Identification
A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Related Devices
- K121857 — FEMMYCYCLE · Femcap Incorporated · Nov 15, 2012
- K021356 — THE DIVACUP MENSTRUAL SOLUTION · Diva International, Inc. · Jul 16, 2002
- K971303 — INSTEAD, SOFTCUP · Ultrafem, Inc. · Jun 6, 1997
- K092985 — BELLECUP · Librette, Inc. · Jun 28, 2010
- K091754 — LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 · Lune Group , Ltd. · Nov 13, 2009
Submission Summary (Full Text)
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Su Hardy Managing Director Mooncup Ltd Dolphin House, 40 Arundel Place Brighton BN2 1GD UNITED KINGDOM
DEC 2 6 2006
Re: K060852
Trade/Device Name: Mooncup Menstrual Cup Regulation Number: 21 CFR 884.5400 Regulation Name: Menstrual cup Regulatory Class: II Product Code: HHE Dated: December 8, 2006 Received: December 18, 2006
Dear Ms. Hardy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image is a circular seal or logo. The text "1906-2006" is at the top of the seal. Below that is the text "PDA Centennial" in a stylized font. There are three stars below the word "Centennial".
Protecting and Promoting Public Health
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known): K060852
Device Name: Mooncup Menstrual Cup
Indications for Use:
The Mooncup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
Prescription Use: NO (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: YES (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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