PelvX Incontinence Ring

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

510(k) Number

K974116 ↗

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 Ring, PelvX Ring with Support

  Class II

  FDA 510(k) K974115 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. →

• Is the PelvX Incontinence Ring intended for single-use or reusable applications, and how does this affect its maintenance or cleaning requirements?

  The PelvX Incontinence Ring is explicitly designed as a reusable medical device. Since it is not sterile upon delivery, it must be cleaned and maintained according to clinical protocols to ensure patient safety and device longevity. The reusable nature means it can be used repeatedly after proper sterilization or disinfection between patients, but it requires adherence to manufacturer guidelines for cleaning and storage to prevent contamination or damage.

• What medical specialties or clinical settings is the PelvX Incontinence Ring primarily used in, and why?

  The PelvX Incontinence Ring is primarily intended for use in obstetrics and gynecology settings, as indicated by its regulatory classification and advisory committee designation. It is designed to support pelvic organs and manage stress urinary incontinence, making it relevant for clinicians specializing in women’s health, pelvic floor disorders, or urology. The device’s mechanism of action—providing mechanical support to the pelvic floor—aligns with the clinical needs of these specialties.

• Does the PelvX Incontinence Ring come in multiple sizes or models, and if so, how might a clinician determine the appropriate fit for a patient?

  While the provided data lists multiple registration numbers (e.g., 3015417614, 3011529681), it does not specify whether these correspond to distinct sizes or models of the PelvX Incontinence Ring. However, vaginal pessaries typically come in varying sizes to accommodate different anatomical structures. Clinicians should refer to the manufacturer’s instructions or sizing guidelines to select the appropriate fit for each patient, ensuring proper support and comfort while minimizing risks like tissue irritation or displacement.

• How is the PelvX Incontinence Ring regulated in the U.S., and what does this mean for its use in clinical practice?

  The PelvX Incontinence Ring is regulated under the FDA’s 510(k) clearance process (K974116) as a Class II device under product code HHW. This classification means it has been determined to be substantially equivalent to a legally marketed device and is subject to special controls for vaginal pessaries, including performance standards and labeling requirements. Clinicians can use it with confidence that it meets FDA safety and effectiveness criteria, though they must still follow manufacturer instructions and local protocols for proper application and patient monitoring.