Skylark Uro Probe

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

510(k) Number

K053007 ↗

FDA Product Code

KPI

Device Class

Class II

Regulation

21 CFR Part 876.5320

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Skylark Infrared Photon Stimulator, Models, Sd-956IR and Sd-100IR

  Class II

  FDA 510(k) K043306 Active Cleared 6 Jun 2005

• Bio-Stim Kit

  Class II

  FDA 510(k) K050174 Active Cleared 7 Sep 2005

• Sds-4I

  Class II

  FDA 510(k) K034005 Active Cleared 18 Nov 2004

• Conductive Gel for Ultrasound

  Class II

  FDA 510(k) K002832 Active Cleared 6 Aug 2001

• Sd-730 If-Sds, Perfect Pulse If-Sds

  Class II

  FDA 510(k) K992652 Active Cleared 3 Feb 2000

• What is the SKYLARK URO PROBE used for?

  The SKYLARK URO PROBE is a non-implantable electrical stimulator device indicated for pelvic floor stimulation in the treatment of urinary incontinence. It also allows assessment of EMG activity of the pelvic floor muscles.

• Is the SKYLARK URO PROBE a single-use or reusable device?

  The device data does not specify whether the SKYLARK URO PROBE is single-use or reusable. This information would need to be obtained directly from the manufacturer or product documentation.

• What regulatory approvals does the SKYLARK URO PROBE have?

  The SKYLARK URO PROBE received FDA 510(k) clearance with number K053007 on December 5, 2005, as substantially equivalent. It is classified under product code KPI and regulation number 876.5320.

• In what medical settings is the SKYLARK URO PROBE intended to be used?

  The device is intended for use in gastroenterology and urology settings. It is not classified as SaMD or involving AI/ML technology.