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Biosonics Continence Control System CCS

by Biosonics, Inc.

510(k) K864448

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK864448 Date6 Feb 1987ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
The Biosonics Continence Control System Ccs(Tm)
510(k) Number
FDA Product Code
KPN
Device Class
Class II
Regulation
21 CFR Part 876.2040
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Biosonics Continence Control System CCS is an alarm device for conditioned response enuresis. It is designed to assist in the management of enuresis through conditioned response training.

This device is classified under regulation number 876.2040 and has received FDA 510(k) clearance under K864448. It is manufactured by Biosonics, Inc. and falls under the gastroenterology and urology medical specialties.

Other devices from Biosonics, Inc.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Biosonics Continence Control System CCS?

    The Biosonics Continence Control System CCS is a medical alarm device specifically designed to assist in the management of enuresis through the application of conditioned response training.

  • What is the regulatory status of the Biosonics Continence Control System?

    This device is classified under regulation number 876.2040 and falls within the gastroenterology and urology medical specialties. It has received FDA 510(k) clearance under the submission number K864448.

  • Who manufactures the Biosonics Continence Control System and how is it categorized?

    The device is manufactured by Biosonics, Inc., which is based in Philadelphia, Pennsylvania. It is categorized as a conditioned response enuresis alarm under product code KPN.