Chesebrough-Pond's Reusable Urinary Leg
by Chesebrough-Pond'S U.S.A. Co.
510(k) K842553
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842553 | Date20 Jul 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Chesebrough-Pond'S U.S.A. Co.
Questions
AI-generated answers, 21 Sep 2026
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.