Identity
- Trade Name
- Niti-S Biliary Speed D Stent FDA UDI
- Generic Name
- Bare-metal biliary stent FDA UDI
- Device Name
- The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent. FDA UDI
- Model / Reference
- BDM1007 FDA UDI
- Description
- The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809909414169 FDA UDI
- 510(k) Number
- K223626 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Bare-metal biliary stent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Stent Diameter — 10 Millimeter FDA UDIStent Length — 70 Millimeter FDA UDICatheter Working Length — 180 Centimeter FDA UDICrossing Profile — 8.5 French FDA UDI
Category: Bare-metal biliary stent
Niti-S Biliary Speed D Stent by Taewoong Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bare-metal biliary stent.
- ALIMAXX-B® — Merit Medical Systems, Inc. · Class II
- PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System — Cordis US Corp. · Class II
- LifeStar® Biliary Stent — Bard Peripheral Vascular · Class II
- SMART FLEX — Cordis US Corp. · Class II
- BONASTENT® Biliary — Sewoon Medical Co., Ltd. · Class II
- Palmaz BLUE Transhepatic Biliary Stent on SLALOM .018 System — Cordis US Corp. · Class II
- Valeo® Balloon Expandable Biliary Stent — Bard Peripheral Vascular · Class II
- E·Luminexx® Biliary Stent — Bard Peripheral Vascular · Class II
Cleared under the same submission
K223626 also covers:
- Niti-S Biliary Speed D Stent — Taewoong Medical
- Niti-S Biliary Speed D Stent — Taewoong Medical
- Niti-S Biliary Speed D Stent — Taewoong Medical
- Niti-S Biliary Speed D Stent — Taewoong Medical
- Niti-S Biliary Speed D Stent — Taewoong Medical
- Niti-S Biliary Speed D Stent — Taewoong Medical
- Niti-S Biliary Speed D Stent — Taewoong Medical
- Niti-S Biliary Speed D Stent — Taewoong Medical
- Niti-S Biliary Speed D Stent — Taewoong Medical
- Niti-S Biliary Speed D Stent — Taewoong Medical
- Niti-S Biliary Speed D Stent — Taewoong Medical
- Niti-S Biliary Speed D Stent — Taewoong Medical
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Taewoong Medical
Sources (1)
- FDA UDI d35da585-444b-4e6c-9883-a87e9fb4b2c7 37 fields · synced May 30, 2026