Mentor Evacare Vaginal Pessaries
by Mentor Corp. United States 510(k)
510(k) K993308 Product code HHW
Overview
The Mentor Evacare Vaginal Pessaries are removable medical devices classified as vaginal pessaries, designed to support pelvic organs. These silicone elastomer devices are intended for use in treating conditions such as uterine prolapse by providing structural support within the vaginal canal. They are manufactured as reusable medical-grade devices, adhering to regulatory standards for Class II devices under product code HHW.
These pessaries are supplied sterile and intended for clinical use in obstetrics and gynecology settings. They are reusable and must be cleaned and maintained according to manufacturer guidelines. The devices are regulated under FDA 510(k) clearance (K993308) and fall under the regulation number 884.3575, with multiple registration numbers listed for tracking. No MRI safety information is specified, and sizes are not detailed in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993308 | Date13 Dec 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HHW
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.3575
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Mentor Corp.
Questions
What are the Mentor Evacare Vaginal Pessaries used for?
The Mentor Evacare Vaginal Pessaries are designed to provide structural support within the vaginal canal, primarily for treating conditions such as uterine prolapse. These silicone elastomer devices help maintain pelvic organ positioning, offering relief for patients experiencing discomfort or functional issues related to prolapse.
Are the Mentor Evacare Vaginal Pessaries single-use or reusable?
The Mentor Evacare Vaginal Pessaries are reusable medical-grade devices. They are supplied sterile for clinical use and must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper hygiene and longevity.
How are these pessaries supplied and where are they used?
These pessaries are supplied sterile and intended exclusively for clinical settings in obstetrics and gynecology. They are not intended for home use without professional supervision and must be handled in accordance with medical protocols to preserve sterility and functionality.
What regulatory approvals do the Mentor Evacare Vaginal Pessaries hold?
The Mentor Evacare Vaginal Pessaries hold FDA 510(k) clearance under the classification of Class II devices, with the clearance number K993308. They are regulated under the product code HHW and fall under the regulation number 884.3575, ensuring compliance with U.S. medical device standards.
Are there any specific storage requirements for these pessaries?
While the provided data does not specify detailed storage instructions, reusable medical devices like these typically require clean, dry storage in a sealed container or pouch to prevent contamination and maintain sterility. Follow the manufacturer’s guidelines for proper cleaning and storage to ensure optimal performance and longevity.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K993308