FDA.reportPublic FDA data

Niti-S Biliary Speed D Stent

Primary DI
08809909414206
Brand
Niti-S Biliary Speed D Stent
Company
TAEWOONGMEDICAL.CO.,LTD
Model
BDM1012
Device 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.
Published
2023-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGEStents, Drains And Dilators For The Biliary Ducts

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223626000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223626000Niti-S Biliary Speed D StentTaewoong Medical Co., Ltd.2023-05-26FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809909414206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809909414206088099094142068809909414206

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal biliary stentA non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length180Centimeter
Crossing Profile8.5French
Stent Diameter10Millimeter
Stent Length120Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
323-692-0028minsoo@taewoongusa.com
+82319960641contact@stent.net

Regulatory Flags#

DUNS number
689484322
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809909424502SphincterotomeOST0720OST07202026-05-29
08809909424519SphincterotomeOST0725OST07252026-05-29
08809909424526SphincterotomeOST0730OST07302026-05-29
08809909424533SphincterotomeOST0720SOST0720S2026-05-29
08809909424540SphincterotomeOST0725SOST0725S2026-05-29
08809909424557SphincterotomeOST0730SOST0730S2026-05-29
08809909421457SnareKSN22FHC-10KSN22FHC-102026-04-27
08809909421464SnareKSN22FHC-15KSN22FHC-152026-04-27
08809909421471SnareKSN22FHC-20KSN22FHC-202026-04-27
08809909421488SnareKSN22FYC-20KSN22FYC-202026-04-27
08809909421709CystotomeOCT1907OCT19072026-04-27
08809909421716CystotomeOCT1908OCT19082026-04-27
08809909421723Biopsy ForcepsJBFR160JBFR1602026-04-27
08809909421730Biopsy ForcepsJBFR160CJBFR160C2026-04-27
08809909421747Biopsy ForcepsBF160BF1602026-04-27
08809909421754Biopsy ForcepsBF160NBF160N2026-04-27
08809909421761Biopsy ForcepsBF160CBF160C2026-04-27
08809909421778Biopsy ForcepsBFR160BFR1602026-04-27
08809909421785Biopsy ForcepsBFR160NBFR160N2026-04-27
08809909421792Biopsy ForcepsBFR160CBFR160C2026-04-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06959664927465NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927496NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664928943NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
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