Identity
- Trade Name
- HANAROSTENT® Esophagus (NCN) FDA UDI
- Generic Name
- Polymer-metal oesophageal stent FDA UDI
- Device Name
- Partially Covered metallic esophagus stent FDA UDI
- Model / Reference
- EPB20110-X070 FDA UDI
- Description
- Partially Covered metallic esophagus stent FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806367095916 FDA UDI
- 510(k) Number
- K201160 FDA UDI
- FDA Product Code
- ESW FDA UDI
- GMDN Term
- Polymer-metal oesophageal stent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3610 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
Yes
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 — 20 Millimeter FDA UDIStent Length — 110 Millimeter FDA UDI
Category: Polymer-metal oesophageal stent
HANAROSTENT® Esophagus (NCN) by M.I.Tech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymer-metal oesophageal stent.
- Esophageal TTS Stent — Taewoong Medical · Class II
- Esophageal TTS Stent — Taewoong Medical · Class II
- Esophageal TTS Stent — Taewoong Medical · Class II
- Esophageal TTS Stent — Taewoong Medical · Class II
- Esophageal TTS Stent — Taewoong Medical · Class II
- HILZO Esophageal stents — BCM Co., Ltd. · Class II
- Esophageal TTS Stent — Taewoong Medical · Class II
- Esophageal TTS Stent — Taewoong Medical · Class II
Cleared under the same submission
K201160 also covers:
- HANAROSTENT® Esophagus (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus (CCC) — M.I.Tech Co., Ltd.
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
- M.I.Tech Co., Ltd.
Sources (1)
- FDA UDI 7aaf766b-b16a-4de8-8f0e-aa004dcbcc25 37 fields · synced May 31, 2026