PelvX Ring, PelvX Ring with Support

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K974115 ↗

FDA Product Code

HHW

Device Class

Class II

Regulation

21 CFR Part 884.3575

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Pelvx Donut, Pelvx Cube

  Class II

  FDA 510(k) K974117 Active Cleared 27 Apr 1998

• Surgactivator

  Class II

  FDA 510(k) K951569 Active Cleared 6 Jun 1995

• Pelvx Incontinence Dish, Model 301-306

  Class II

  FDA 510(k) K990593 Active Cleared 24 May 1999

• PelvX Incontinence Ring

  Class II

  FDA 510(k) K974116 Active Cleared 27 Apr 1998

• Reflex Treatment System

  Class II

  FDA 510(k) K994079 Active Cleared 1 Mar 2000

• Pelvx Gellhorn Vaginal Pessary 603-608

  Class II

  FDA 510(k) K002329 Active Cleared 18 Sep 2000

See all devices from Deschutes Medical Products, Inc. →

• What is the PelvX Ring used for?

  The PelvX Ring is a vaginal pessary designed to support pelvic organs in obstetrics and gynecology. It is classified as a Class II medical device under 21 CFR 884.3575.

• Is the PelvX Ring reusable or single-use?

  The PelvX Ring is supplied as a single-use item and is not reusable. It should be discarded after one use according to the manufacturer's instructions.

• What is the regulatory status of the PelvX Ring?

  The PelvX Ring has received FDA 510(k) clearance (K974115) on April 27, 1998, and is classified as a Class II medical device under 21 CFR 884.3575.

• Is the PelvX Ring MRI safe?

  No, the PelvX Ring is not specified as MRI safe. Patients should inform their healthcare provider if they are scheduled for an MRI examination.