NovoFlow Reinforced Ureteral Stent
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213186 FDA 510(k)
- FDA Product Code
- FAD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4620 FDA 510(k)
- Regulation Number
- 876.4620 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESK Substantially Equivalent — Kit FDA 510(k)
The NovoFlow Reinforced Ureteral Stent is a medical device classified as a ureteral stent, designed to facilitate drainage of the upper urinary tract and promote ureteral healing in cases of ureteral stenosis. Its reinforced structure enhances resistance to compression and enables passage through strictures, while the absence of drainage holes in the straight section helps prevent tumoral tissue ingrowth.
This device is supplied as a single-use, Class II medical product and is intended for use in adult and pediatric (adolescent) patients aged 12 years or over (weighing 40 kg or more). It is regulated under FDA 510(k) clearance (K213186) and is intended for drainage of the upper urinary tract, including management of ureteral stenosis. Multiple sizes are available, as indicated by the registration numbers, and it is not MRI-safe.
Frequently asked questions
What is the NovoFlow Reinforced Ureteral Stent specifically designed to address in patients with urinary tract issues?
The NovoFlow Reinforced Ureteral Stent is designed to facilitate drainage of the upper urinary tract while promoting healing in cases of ureteral stenosis. Its reinforced structure helps resist compression and allows passage through strictures, reducing the risk of blockages. The absence of drainage holes in the straight section also helps prevent tumoral tissue ingrowth, making it suitable for complex cases.
Is the NovoFlow Reinforced Ureteral Stent suitable for both adults and adolescents, and what is the minimum weight requirement?
Yes, the NovoFlow Reinforced Ureteral Stent is intended for use in adult and pediatric (adolescent) patients aged 12 years or older, with a minimum weight requirement of 40 kg. This ensures it can be safely used in larger children and adolescents while addressing their urinary drainage needs.
How many different sizes are available for the NovoFlow Reinforced Ureteral Stent, and how would I determine the correct size for a patient?
Multiple sizes are available for the NovoFlow Reinforced Ureteral Stent, as indicated by the registration numbers listed in the FDA database (e.g., 2527072, 3021632375, etc.). The correct size should be selected based on clinical assessment, including the patient’s anatomy and the specific medical indication, such as the degree of ureteral stenosis or stricture. Consulting the manufacturer’s sizing guidelines or a urologist is recommended to ensure proper fit and function.
Is the NovoFlow Reinforced Ureteral Stent intended for single-use only, and what does this mean for storage and handling?
Yes, the NovoFlow Reinforced Ureteral Stent is supplied as a single-use device. This means it should not be reused after a single procedure to maintain sterility and safety. Proper storage in a clean, dry environment, away from direct sunlight or extreme temperatures, is essential to preserve its integrity until use. Always follow the manufacturer’s storage instructions to ensure the device remains sterile and functional.
Can the NovoFlow Reinforced Ureteral Stent be used in MRI procedures, and why is this important to know?
No, the NovoFlow Reinforced Ureteral Stent is explicitly stated as *not* MRI-safe. This is important because MRI procedures involve strong magnetic fields, and non-MRI-safe devices could pose risks such as displacement, heating, or damage to the stent or surrounding tissues. Always verify compatibility with imaging modalities before or during patient care.
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: NovoFlow™ Reinforced Ureteral Stent - Coloplast, Stent - Coloplast, NovoFlow Reinforced Ureteral Stent (K213186) — FDA 510 (k) | Innolitics, NovoFlow Reinforced Ureteral Stent (K213186) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213186 | Class II | Active |
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Manufacturer
- Manufacturer
- Coloplast Corp.
Sources (1)
- FDA 510(k) K213186 24 fields · synced Sep 19, 2026