Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250663 FDA 510(k)
- FDA Product Code
- MUM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3610 FDA 510(k)
- Regulation Number
- 878.3610 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent are self-expanding, metallic stents designed for palliative treatment of malignant obstructions in the duodenum and colon. These devices are classified as Class II medical devices and fall under the regulatory category for expandable, metallic stents. Their primary function is to restore luminal patency by mechanically supporting the gastrointestinal tract, thereby alleviating symptoms associated with obstruction.
These stents are supplied sterile and intended for single-use. They are regulated under FDA 510(k) clearance (K250663) and fall under the product code MUM, with a decision classification of substantially equivalent (SESE). The devices are intended for use in a clinical setting by trained medical professionals and are not MRI-safe. Available in multiple sizes and configurations, they are packaged for immediate clinical deployment and require no additional preparation beyond standard sterile procedures.
Frequently asked questions
What are the Niti-S Duodenal and Colonic Comfort Stents primarily used for?
These stents are designed for palliative treatment of malignant obstructions in the duodenum and colon. They mechanically support the gastrointestinal tract to restore luminal patency, thereby alleviating symptoms caused by blockages. The self-expanding metallic design ensures sustained mechanical support where obstructions occur.
Are the Niti-S Duodenal and Colonic Comfort Stents sterile and single-use?
Yes, the stents are supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and reduces the risk of infection. The packaging is optimized for immediate clinical deployment, requiring no additional preparation beyond standard sterile procedures.
What sizes and configurations are available for these stents?
The Niti-S Duodenal and Colonic Comfort Stents come in multiple sizes and configurations to accommodate different anatomical needs. While exact dimensions are not specified here, the variety ensures compatibility with various patient anatomies and obstruction sites. The manufacturer provides detailed sizing guidance for clinical selection.
How should these stents be stored before use?
The stents should be stored in their original, sealed packaging to maintain sterility. They must be kept in a clean, dry environment, protected from extreme temperatures and direct sunlight. The packaging is designed for immediate clinical use, so no additional preparation is required beyond adhering to standard sterile field protocols.
Are these stents MRI-safe?
No, the Niti-S Duodenal and Colonic Comfort Stents are not MRI-safe. This means they should not be used in patients who require MRI imaging, as the metallic composition could interfere with the scan or pose safety risks. Clinicians should verify MRI compatibility before use if imaging is anticipated.
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: Niti-S Colonic and Duodenal Comfort Stents - TaeWoong Medical USA, Niti-S GI Stent Portfolio - TaeWoong Medical USA, PRODUCT | Niti-S™ Gastrointestinal Metallic Stent - Taewoong Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250663 | Class II | Active |
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Manufacturer
- Manufacturer
- Taewoong Medical Co., Ltd.
Sources (1)
- FDA 510(k) K250663 24 fields · synced Oct 5, 2026