Urine Collector Leg Bag
510(k) K896688
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK896688 | Date2 May 1990 | 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- Withdrawn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, 1 Oct 2026
The Urine Collector Leg Bag is a medical device classified as a collector for urine, designed to accommodate an indwelling catheter. It is intended for the temporary collection and drainage of urine from patients who are unable to ambulate or require continuous urinary drainage, such as those with urinary incontinence or catheterization needs. The device helps prevent urine leakage and maintains hygiene by securely holding urine away from the body.
This device is supplied as a single-use, sterile product and is intended for use in clinical settings such as hospitals, nursing homes, and home healthcare environments. It is regulated under FDA 510(k) clearance (K896688) and falls under the classification of Class II medical devices (regulation number 876.5250). The bag is designed to be attached to a patient’s leg via adhesive or straps, ensuring stability and comfort during use. Multiple sizes and variants may be available, as indicated by associated product codes.
Other devices from Medline Industries, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Urine Collector Leg Bag used for?
The Urine Collector Leg Bag is designed for the temporary collection and drainage of urine from patients who cannot walk or require continuous urinary drainage, such as those with urinary incontinence or catheterization needs. It securely holds urine away from the body, reducing leakage and promoting hygiene by attaching to the patient’s leg via adhesive or straps.
Is the Urine Collector Leg Bag single-use or reusable?
The Urine Collector Leg Bag is intended for single-use only. This ensures sterility and reduces the risk of contamination or infection, which is critical in clinical settings like hospitals, nursing homes, or home healthcare environments.
How is the Urine Collector Leg Bag supplied and stored?
The device is supplied as a sterile, single-use product, ready for immediate clinical use. It should be stored in its original packaging until use to maintain sterility. Avoid exposure to extreme temperatures or direct sunlight, and ensure the packaging remains intact until deployment.
What sizes or variants are available for the Urine Collector Leg Bag?
Multiple sizes and variants of the Urine Collector Leg Bag are available, as indicated by the associated product codes (e.g., KNX). These variations likely cater to different patient needs, such as varying urine volumes or leg sizes, ensuring a comfortable and secure fit for diverse clinical scenarios.
How is the Urine Collector Leg Bag attached to a patient?
The bag is designed to be attached to a patient’s leg using either adhesive strips or adjustable straps. This secure attachment ensures stability and comfort during use, preventing accidental detachment and maintaining proper drainage of urine from an indwelling catheter.