Uro Med Nerve Stimulator

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K970971 ↗

FDA Product Code

ETN

Device Class

Class II

Regulation

21 CFR Part 874.1820

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Uromed Patch

  Class I

  FDA 510(k) K974600 Active Cleared 31 Mar 1998

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  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 Uro Med Nerve Stimulator used for?

  The Uro Med Nerve Stimulator is a device that stimulates nerves and is used in medical procedures. It is classified as a nerve stimulator, designed for nerve stimulation applications during various medical treatments.

• Is the Uro Med Nerve Stimulator single-use or reusable?

  The Uro Med Nerve Stimulator is supplied as either a single-use or reusable device, depending on the specific model or configuration selected for the medical procedure.

• What are the storage requirements for the Uro Med Nerve Stimulator?

  The Uro Med Nerve Stimulator should be stored at room temperature. It is not MRI safe, so proper storage away from MRI environments is necessary to maintain device integrity and functionality.

• What regulatory clearance does the Uro Med Nerve Stimulator have?

  The Uro Med Nerve Stimulator has FDA 510K clearance, which means it has been determined to be substantially equivalent to other legally marketed devices of the same type. This clearance was received on October 27, 1997.