Identity
- Trade Name
- HANAROSTENT® Esophagus (CCC) FDA UDI
- Generic Name
- Polymer-metal oesophageal stent FDA UDI
- Device Name
- Full Covered metallic esophagus stent FDA UDI
- Model / Reference
- HES-18-150-070 FDA UDI
- Description
- Full Covered metallic esophagus stent FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806367004208 FDA UDI
- 510(k) Number
- K093537 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
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 150 Millimeter FDA UDILumen/Inner Diameter — 18 Millimeter FDA UDI
Category: Polymer-metal oesophageal stent
HANAROSTENT Esophagus (CCC) is a fully covered metallic esophagus stent designed to maintain luminal patency in strictures, prevent tumour in-growth, seal oesophageal fistulas, reduce acute bleeding from oesophageal varices, and/or treat other lesions causing oesophageal leakage. This polymer-metal stent is typically expanded in situ and disposable devices intended for implantation may be included.
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
K093537 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.
Authorization Coverage (1 country)
Regulatory Authorizations
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 72b7c433-6679-4c46-baa5-5452a460bebe 37 fields · synced Jul 26, 2026