Identifiers
- 510(k) Number
- K242049 FDA 510(k)
- FDA Product Code
- EZD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5130 FDA 510(k)
- Regulation Number
- 876.5130 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SureCath® Set with Insertion Supplies - Coloplast, SureCath Sets by Coloplast - medicalsupplydirectusa.com, SureCath Set - Coloplast, Coloplast SureCath Set | Closed System Catheters | 180 Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242049 | Class II | Active |
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Manufacturer
- Manufacturer
- Coloplast Corp.
Sources (1)
- FDA 510(k) K242049 24 fields · synced Sep 26, 2026