Anotron Incontinence Control System

No FDA recalls found in the data synced 5 Oct 2026.

Full name

Anotron(R) Incontinence Control System

510(k) Number

K882555 ↗

FDA Product Code

KPN

Device Class

Class II

Regulation

21 CFR Part 876.2040

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Biosonics Continence Control System CCS

  Class II

  FDA 510(k) K864448 Active Cleared 6 Feb 1987

• Biosoics Sphincter Training System

  Class II

  FDA 510(k) K862683 Active Cleared 12 Nov 1986

• Salitron System

  Class II

  FDA PMA P860067 Active Approved 17 May 1988

• What is the Anotron Incontinence Control System used for?

  The Anotron Incontinence Control System is designed as a Conditioned Response Enuresis Alarm to treat anal incontinence. It works by delivering auditory and tactile stimuli to help patients associate early bladder or bowel sensations with voluntary control, effectively training them to respond appropriately. This system is intended for clinical use in gastroenterology and urology settings as a non-invasive training aid, not as a direct therapeutic intervention.

• How is the Anotron Incontinence Control System supplied and maintained?

  The Anotron Incontinence Control System is supplied as a reusable medical electronic device, meaning it is intended for repeated use in clinical environments. While no specific sterility requirements are explicitly stated in regulatory documentation, proper cleaning and maintenance of reusable components are implied to ensure safe and effective operation. Follow manufacturer guidelines for disinfection and upkeep to prevent contamination and prolong device lifespan.

• Is the Anotron Incontinence Control System single-use or reusable?

  The Anotron Incontinence Control System is not single-use; it is classified as a reusable medical electronic device. The FDA’s 510(k) clearance (K882555) and regulatory classification confirm its intended reuse in clinical settings. Proper cleaning and maintenance protocols must be followed to ensure hygiene and functionality between uses.

• What regulatory pathway was followed for the Anotron Incontinence Control System?

  The Anotron Incontinence Control System was cleared through the FDA’s 510(k) pathway, specifically under the Gastroenterology-Urology (GU) advisory committee. The submission (K882555) received a Substantially Equivalent (SESE) determination, confirming it meets regulatory standards for an Alarm device (FDA regulation 876.2040) used in incontinence training. The device’s classification and product code (KPN) align with its intended use.

• Does the Anotron Incontinence Control System require special storage or handling?

  While specific storage instructions aren’t detailed in the regulatory data, as a reusable medical electronic device, the Anotron Incontinence Control System should be stored in a clean, dry environment when not in use. Protect it from physical damage, moisture, and extreme temperatures to preserve functionality. Follow manufacturer-recommended guidelines for maintenance and storage to ensure optimal performance and longevity.