Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
510(k) K221593
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK221593 | Date17 Nov 2022 | 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- Withdrawn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
- EZD
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Cure Ultra Male, Cure Ultra Female, and Cure Ultra Plus are straight catheters designed for intermittent self-catheterization. These devices are intended for draining urine from the bladder in male, female, and unisex users, respectively. The Cure Ultra Male includes a gripper sleeve for controlled insertion, while the female and unisex models are tailored to anatomical needs. All models feature fire-polished eyelets to enhance comfort and a pre-lubricated design for ease of use.
These catheters are supplied as sterile, single-use devices, ensuring hygiene and reducing cross-contamination risk. They are classified as Class II medical devices under FDA regulations and have received 510(k) clearance through the Traditional pathway, with a decision of Substantially Equivalent. The Cure Ultra series is intended for use in clinical settings such as home care, hospitals, and outpatient facilities. Each model is packaged in flexible, kink-resistant materials for portability and convenience, with no MRI safety restrictions specified. Storage should follow manufacturer guidelines for sterile single-use devices.
Other devices from Convatec, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Cure Ultra Male catheter designed for?
The Cure Ultra Male catheter is specifically designed for intermittent self-catheterization in male users. It is intended to drain urine from the bladder safely and efficiently. The inclusion of a gripper sleeve helps users achieve controlled insertion, reducing discomfort and improving ease of use.
Are the Cure Ultra catheters single-use or reusable?
The Cure Ultra catheters (Male, Female, and Plus) are supplied as sterile, single-use devices. This design ensures hygiene and minimizes the risk of cross-contamination, which is critical for preventing infections during catheterization.
How are the Cure Ultra Female and Cure Ultra Plus catheters different?
The Cure Ultra Female catheter is tailored to the anatomical needs of female users, while the Cure Ultra Plus is designed as a unisex option. Both feature fire-polished eyelets for enhanced comfort and are pre-lubricated for easier insertion, but their shapes and lengths differ to accommodate specific user anatomies.
What packaging materials are used for the Cure Ultra catheters?
The Cure Ultra catheters are packaged in flexible, kink-resistant materials. This packaging ensures portability and convenience for users in clinical settings like home care, hospitals, and outpatient facilities, while maintaining sterility.
How should the Cure Ultra catheters be stored?
The Cure Ultra catheters should be stored according to the manufacturer’s guidelines for sterile single-use devices. This typically involves keeping them in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until use.