PELVX RING, PELVX RING WITH SUPPORT

• K Number: K974115
• Device Name: PELVX RING, PELVX RING WITH SUPPORT
• Manufacturer: DESCHUTES MEDICAL PRODUCTS, INC.
• Date Cleared: 1998-04-27 ( 178 days)
• Product Code: HHW
• Regulation Number: 884.3575
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: N/A

Intended Use

The PelvX Ring Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse.

The PelvX Ring with Support Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse combined with mild cystocele.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the PelvX Ring Vaginal Pessary and PelvX Ring with Support Vaginal Pessary, indicating that the device has been found substantially equivalent to predicate devices. It outlines the regulatory classification, indications for use, and general responsibilities but does not detail performance criteria or associated studies.

Regulation Number and Section

§ 884.3575 Vaginal pessary.

(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).