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HANAROSTENT Benefit Biliary (NNN)

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K202973

by M.I.Tech Co., Ltd.

Identity

Trade Name
HANAROSTENT® Benefit™ Biliary (NNN) FDA UDI
Generic Name
Bare-metal biliary stent FDA UDI
Device Name
Un-covered self-expanding nitinol biliary stent FDA UDI
Model / Reference
BNHS-06-120-180 FDA UDI
Description
Un-covered self-expanding nitinol biliary stent FDA UDI

Identifiers

Primary DI / UDI-DI
08806367092908 FDA UDI
510(k) Number
K202973 FDA 510(k)FDA UDI
FDA Product Code
FGE FDA 510(k)FDA UDI
GMDN Term
Bare-metal biliary stent FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 876.5010 FDA 510(k)
Regulation Number
876.5010 FDA 510(k)FDA UDI
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESU FDA 510(k)
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
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Stent Diameter — 6 Millimeter FDA UDI
Stent Length — 120 Millimeter FDA UDI

HANAROSTENT Benefit Biliary (NNN) by M.I.Tech Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
M.I.Tech Co., Ltd.

Sources (2)

  • FDA 510(k) K202973 24 fields · synced Jun 18, 2026
  • FDA UDI 3a249c0e-c3bf-4029-aaac-ece35c46097e 37 fields · synced May 27, 2026