Esophageal TTS Stent

FDA UDI

Class II (US FDA UDI)

by Taewoong Medical

Identity

Trade Name: Esophageal TTS Stent FDA UDI
Generic Name: Polymer-metal oesophageal stent FDA UDI
Device Name: Fully Covered Esophageal Stent System FDA UDI
Model / Reference: EST1808F FDA UDI
Description: Fully Covered Esophageal Stent System FDA UDI

Identifiers

Catalog Number: EST1808F FDA UDI
Primary DI / UDI-DI: 08809293830316 FDA UDI
510(k) Number: K113551 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

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 18 Millimeter FDA UDI
Length — 8 Centimeter FDA UDI
Catheter Gauge — 10.5 French FDA UDI

Category: Polymer-metal oesophageal stent

Esophageal TTS Stent by Taewoong Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymer-metal oesophageal stent.

HANAROSTENT® Esophagus TTS(NCN) — M.I.Tech Co., Ltd. · Class II
HANAROSTENT® Esophagus TTS(CCC) — M.I.Tech Co., Ltd. · Class II
HANAROSTENT® Esophagus (NCN) — M.I.Tech Co., Ltd. · Class II
HILZO Esophageal stents — BCM Co., Ltd. · Class II
HANAROSTENT® Esophagus TTS(CCC) — M.I.Tech Co., Ltd. · Class II
HILZO Esophageal stents — BCM Co., Ltd. · Class II
EndoMAXX® — Merit Medical Systems, Inc. · Class II
BONASTENT® Esophageal — Sewoon Medical Co., Ltd. · Class II

Cleared under the same submission

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 688ecfc8-122a-4aca-8eec-5d003047d2ee 38 fields · synced May 30, 2026