CoralWell Single-use Ureteral Access Sheath - NS-1235B
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250452 FDA 510(k)
- FDA Product Code
- FED FDA 510(k)
- Models / Variants
- NS-1235B FDA 510(k)EUDAMED
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CoralWell Single-use Ureteral Access Sheath is classified as an Endoscopic Access Overtube, designed to facilitate ureteral access procedures. It provides a protective pathway for instruments and catheters during interventions such as ureteroscopy, allowing for improved maneuverability and reduced trauma to the ureteral walls.
These single-use devices are intended for use in urological settings and are supplied sterile. Each model (e.g., NS-0835B) corresponds to specific sizes for compatibility with various ureteral anatomies. Authorized under FDA 510K and MDR, they adhere to regulatory standards for medical devices in gastroenterology and urology, ensuring compliance with safety and performance requirements.
Frequently asked questions
What is the CoralWell Single-use Ureteral Access Sheath primarily used for in clinical settings?
The CoralWell Single-use Ureteral Access Sheath is designed as an Endoscopic Access Overtube to facilitate ureteral access procedures, such as ureteroscopy. It provides a protective pathway for instruments and catheters, improving maneuverability and reducing trauma to the ureteral walls during interventions.
Are these devices reusable or intended for single-use, and how should they be handled post-procedure?
The CoralWell Ureteral Access Sheath is explicitly labeled as single-use only. After a procedure, the device should be discarded in accordance with standard medical waste protocols to prevent cross-contamination and ensure patient safety.
How do I determine the correct size for a patient’s anatomy when selecting a CoralWell model?
Each CoralWell model (e.g., NS-0835B) corresponds to specific sizes tailored for compatibility with different ureteral anatomies. The manufacturer provides sizing guidelines—check the product documentation or consult with the supplier to match the patient’s anatomy to the appropriate model.
Are these devices sterile upon arrival, and if so, what precautions should be taken during storage?
Yes, the CoralWell Single-use Ureteral Access Sheath is supplied sterile. Store the devices in their original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures, to maintain sterility until use. Avoid opening the packaging until immediately before the procedure.
What regulatory pathways have been followed for this device, and which agencies have authorized its use?
The CoralWell Single-use Ureteral Access Sheath has been authorized under FDA 510K and the EU Medical Device Regulation (MDR). These pathways confirm compliance with safety and performance standards for endoscopic access devices in urology and gastroenterology.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K250452 | Class II | Active |
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Manufacturer
- Manufacturer
- MacroLux Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K250452 24 fields · synced Oct 7, 2026
- EUDAMED 1 fields · synced Jun 11, 2026