FAD — Stent, Ureteral Class II

FDA Device Classification

Classification Details

Product Code
FAD
Device Class
Class II
Regulation Number
876.4620
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251890zhejiang chuangxiang medical technology coDisposable Ureteral StentsFebruary 20, 2026
K251469cathegenix (xiamen) coEndura™ Ureteral Stent and Stent SetDecember 19, 2025
K243039alton (shanghai) medical instruments coUreteral Stents (AF-D series)June 18, 2025
K243830shenzhen trious medical technology coDisposable ureteral stentMay 14, 2025
K250824boston scientific corporationPercuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrivApril 15, 2025
K232920ureteral stentRELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent March 22, 2024
K211934boston scientific corporationAPDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APNovember 10, 2022
K213185coloplastImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone doubJune 8, 2022
K213444ureteral stentRELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent KiMarch 17, 2022
K213186coloplastNovoFlow Reinforced Ureteral StentFebruary 16, 2022
K212868rocamed samJFil Ureteral Stents, JFil Ureteral Stents ECO KITJanuary 26, 2022
K200260boston scientific corporationPercuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex April 26, 2021
K201436coloplastVortek Single Loop Ureteral StentFebruary 25, 2021
K191446boston scientific corporationUreteral Stent Systems, Biliary Drainage CathetersJanuary 2, 2020
K190659allwin medical devicesUreteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via UreterDecember 2, 2019
K190312dornier medtech americaDornier Ureteral StentNovember 15, 2019
K191609boston scientific corporationTria Soft Ureteral StentAugust 16, 2019
K190603boston scientific corporationTria Firm Ureteral StentMay 24, 2019
K181971cook incorporatedBander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent SetApril 23, 2019
K180557cook incorporatedGreene Renal Transplant Stent SetNovember 23, 2018