FDA.reportPublic FDA data

Niti-S Colonic Comfort Stent

Primary DI
08809909414381
Brand
Niti-S Colonic Comfort Stent
Company
TAEWOONGMEDICAL.CO.,LTD
Model
CDT2210N-22
Device description
The Niti-S Colonic 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
MQRStent, Colonic, Metallic, Expandable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQRStent, Colonic, Metallic, ExpandableGeneral, 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
08809909414381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809909414381088099094143818809909414381

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length220Centimeter
Crossing Profile10French
Stent Diameter22Millimeter
Stent Length100Millimeter

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
08809909421839Biopsy ForcepsGBFR160CGBFR160C2026-04-27
08809744975702Esophageal TTS StentEST1814BEST1814B2022-06-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536219681Small VBR (ADD)Ulrich GmbH & Co. KGMQR2026-03-03
04052536219605ADDUlrich GmbH & Co. KGMQR2025-08-25
04052536009510ADDUlrich GmbH & Co. KGMQR2024-10-29
08809909414367Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414374Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414398Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414404Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414411Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414428Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414435Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08714729902584WallFlex™ ColonicBOSTON SCIENTIFIC CORPORATIONMQR2020-05-26
08714729902591WallFlex™ ColonicBOSTON SCIENTIFIC CORPORATIONMQR2020-05-26
08714729902607WallFlex™ ColonicBOSTON SCIENTIFIC CORPORATIONMQR2020-05-26
08806367080790HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080820HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080851HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080868HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080899HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080929HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080516HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080547HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080578HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080585HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080615HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080646HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080653HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080684HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080714HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080721HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080752HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18