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Pelvx Incontinence Dish, Model 301-306

by Deschutes Medical Products, Inc.

510(k) K990593

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK990593 Date24 May 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PelvX Incontinence Dish is a vaginal pessary (product code HHW) designed to provide support for the cervical and bladder regions. It is dish-shaped and intended for use in managing stress urinary incontinence, particularly when combined with mild first- or second-degree uterine prolapse or a mild cystocele. Constructed as a reusable medical device, it incorporates a bulbous portion along its circumference to enhance stability and support within the vaginal canal.

Supplied in reusable form, the device is manufactured from medical-grade silicone and is intended for clinical use in obstetrics and gynecology settings. It falls under FDA Class II with Special Controls and holds a FDA 510(k) clearance (K990593) issued in 1999. The device is not described as sterile or single-use in regulatory documentation, and no MRI safety information is provided. Sizes are specified by model numbers (301–306), which must be referenced for proper selection.

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