SureCath Set
510(k) K242049
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242049 | Date26 Nov 2024 | StatusActive |
Official records
- FDA 510(k) database K242049
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- Withdrawn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, 26 Sep 2026
The SureCath Set is a closed-system catheter that includes a hydrophilic-coated catheter, sterile saline solution, and urine bag. It is designed for intermittent catheterization and allows users to catheterize anywhere while remaining in their wheelchair when emptying.
The SureCath Set is supplied as a sterile, single-use device. It is classified under product code EZD and has FDA 510(k) clearance with decision code SESE. The device is intended for use in gastroenterology and urology settings.
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Other devices filed under FDA product code EZD (Catheter, Straight).
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- MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER by Mentor Corp.
- LOFRIC SINGLE USE URINARY CATHETER by Astra Tech, Inc.