PELVX GELLHORN VAGINAL PESSARY 603-608 by DESCHUTES MEDICAL PRODUCTS, INC. | FDA 510(k) Summary

FDA 510(k) Search

K Number

Validate with FDA (Live)

Device Name

PELVX GELLHORN VAGINAL PESSARY 603-608

Manufacturer

DESCHUTES MEDICAL PRODUCTS, INC.

Date Cleared

2000-09-18

(48 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

Intended Use

Device Description

AI/ML Overview

Summary

Loading...

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).