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Chesebrough-Pond's Reusable Urinary Leg

by Chesebrough-Pond'S U.S.A. Co.

510(k) K842553

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK842553 Date20 Jul 1984ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KNX
Device Class
Class II
Regulation
21 CFR Part 876.5250
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

The Chesebrough-Pond's Reusable Urinary Leg is a collector for urine and accessories for an indwelling catheter. It is designed to collect and store urine drainage from patients requiring catheterization.

This device is a reusable product that has received FDA 510(k) clearance. It is categorized under the Gastroenterology and Urology medical specialty.

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Questions

AI-generated answers, 21 Sep 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 Chesebrough-Pond's Reusable Urinary Leg?

    This device is designed to function as a collector and accessory for an indwelling catheter, specifically used to collect and store urine drainage from patients who require catheterization.

  • Is this device intended for single-use or can it be reused?

    The device is explicitly classified as a reusable product, meaning it is designed to be cleaned and used multiple times for urine collection as part of a catheterization regimen.

  • What is the regulatory status of this device?

    The Chesebrough-Pond's Reusable Urinary Leg has received FDA 510(k) clearance, which indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices in the gastroenterology and urology specialty.