Reliance Urinary Control Insert and Sizing Device

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

Full name

Reliance Urinary Control Insert & Sizing Device

Trade Name

Reliance Urinary Control Insert and Sizing Device

Generic Name

Transurethral occlusion insert, urinary incontinence-control, female

PMA Number

P960020 ↗

FDA Product Code

OCK

Device Class

Class III

Advisory Committee

Gastroenterology, Urology

FDA Decision

APPR Approved

• Uromed Patch

  Class I

  FDA 510(k) K974600 Active Cleared 31 Mar 1998

• Modification to Cavermap Surgical Aid

  Class I

  FDA 510(k) K010098 Active Cleared 1 Feb 2001

• Uromed Needle Grasper

  Class II

  FDA 510(k) K974137 Active Cleared 30 Jan 1998

• Cavermap Surgical Aid

  Class II

  FDA 510(k) K000507 Active Cleared 21 Apr 2000

• Uromed Sling Kit

  Class II

  FDA 510(k) K980717 Active Cleared 22 May 1998

• Uromed Alternative Bladder Control Continence Device(Abcpn-0026)

  Class I

  FDA 510(k) K971992 Active Cleared 1 Aug 1997

See all devices from Uromed Corp. →

• What is the Reliance Urinary Control Insert and Sizing Device used for?

  The device is a transurethral occlusion insert designed for urinary incontinence control in females. It works by providing mechanical occlusion of the urethra to manage incontinence, as specified in its generic name and FDA documentation.

• Who manufactures the Reliance Urinary Control Insert and Sizing Device and where are they located?

  The device is manufactured by Uromed Corp., located at 64 A St., Needham, MA 02194, as stated in the applicant and address fields of the device data.

• What regulatory authorization does the Reliance Urinary Control Insert and Sizing Device have?

  The device has FDA PMA approval, with approval number P960020, as indicated in the AUTHORIZATIONS and pma_number fields. The ao_statement confirms 'APPROVAL FOR THE RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE'.