FDA.reportPublic FDA data

510(k) K252648

Device
Niti-S SPAXUS Stent
Applicant
Taewoong Medical Co., Ltd.
510(k) number
K252648
Product code
PCU
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-13
Date received
2025-08-21
Regulation
876.5015
Classification name
Pancreatic Stent, Covered, Metallic, Removable
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Yongjin "Jeff" Kim
Address
14, Gojeong-Ro Wolgot-Myeon, Gimpo-Si Gyeonggi-Do KR 10022 10022

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PCU#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220112AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation2022-09-07
K203132AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation2021-04-15
K192043AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation2019-08-26
K181905AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation2019-03-25
K163272AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation2017-02-18
K153088AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery SystemBoston Scientific Corporation2015-12-11
K152572AXIOS Stent and Delivery SystemBoston Scientific Corporation2015-10-06
K150692AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp2015-08-05
K140561AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)Xlumena, Inc.2014-04-23
DEN130007AXIOS STENT AND DELIVERY SYSTEMXlumena, Inc.2013-12-18