FDA.reportPublic FDA data

Niti-S Duodenal Comfort Stent

Primary DI
08809909414336
Brand
Niti-S Duodenal Comfort Stent
Company
TAEWOONGMEDICAL.CO.,LTD
Model
PDT2208N-22
Device description
The Niti-S Duodenal Comfort Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent.
Published
2023-06-20
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
MUMStent, Metallic, Expandable, Duodenal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUMStent, Metallic, Expandable, DuodenalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223067000
K250663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223067000Niti-S Duodenal Stent; Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd.2023-06-14MUM
K250663000Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd.2025-03-31MUM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809909414336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809909414336088099094143368809909414336

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal duodenal stentA sterile non-bioabsorbable tubular device intended to be implanted in the lumen of the duodenum for the palliative treatment of duodenal strictures caused by malignant neoplasms; it is typically used to help eliminate gastric outlet obstructions. It is typically a mesh structure made entirely of metal (e.g., high-grade stainless steel); it is typically expanded 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 Length220Centimeter
Crossing Profile10French
Stent Diameter22Millimeter
Stent Length80Millimeter

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809909414329Niti-S Duodenal Comfort StentTAEWOONGMEDICAL.CO.,LTDMUM2023-06-20
08809909414343Niti-S Duodenal Comfort StentTAEWOONGMEDICAL.CO.,LTDMUM2023-06-20
08809909414350Niti-S Duodenal Comfort StentTAEWOONGMEDICAL.CO.,LTDMUM2023-06-20
08714729902492WallFlex™ DuodenalBOSTON SCIENTIFIC CORPORATIONMUM2020-05-26
08714729902508WallFlex™ DuodenalBOSTON SCIENTIFIC CORPORATIONMUM2020-05-26
08714729902515WallFlex™ DuodenalBOSTON SCIENTIFIC CORPORATIONMUM2020-05-26
08806367081070HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081100HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081131HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081148HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081179HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081209HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081216HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081247HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081278HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081285HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081315HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081346HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367076496HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076526HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076557HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076564HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076595HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076625HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076632HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076663HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076694HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076700HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076731HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076762HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20