ClearanceBrief
Panels › Gastroenterology, Urology › Product code FAD · Class 2

Stent, Ureteral

Regulation 876.4620

2510(k)s in 12 months (122 all time)
4recalls in 12 months (55 all time)
49recalls that name a 510(k)
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Top companies in FAD

Company510(k)sRecalls
Cook Incorporated138
Vance Products Incorporated018
Boston Scientific Corp125
C.R. Bard, Inc.78
Applied Medical Resources56
Hobbs Medical, Inc.19
Surgitek90
Mentor Corp.80
Coloplast Corp.70
Cook Urological, Inc.51
Decided510(k)Device and applicantCode
Feb 20, 2026K251890Disposable Ureteral Stents
Zhejiang Chuangxiang Medical Technology Co., Ltd., CN
FAD
Dec 19, 2025K251469Endura™ Ureteral Stent and Stent Set
Cathegenix (Xiamen) Co., Ltd., CN
FAD
Jun 18, 2025K243039Ureteral Stents (AF-D series)
Alton (Shanghai) Medical Instruments Co., Ltd., CN
FAD
May 14, 2025K243830Disposable ureteral stent
Shenzhen Trious Medical Technology Co., Ltd., CN
FAD
Apr 15, 2025K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour
Boston Scientific Corporation
FAD
Mar 22, 2024K232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
Ureteral Stent Company
FAD
Nov 10, 2022K211934APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dis
Boston Scientific Corporation
FAD
Jun 8, 2022K213185ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Sten
Coloplast Corp.
FAD
Mar 17, 2022K213444RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
Ureteral Stent Company
FAD
Feb 16, 2022K213186NovoFlow Reinforced Ureteral Stent
Coloplast Corp.
FAD
Jan 26, 2022K212868JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
Rocamed Sam, MC
FAD
Apr 26, 2021K200260Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anc
Boston Scientific Corporation
FAD
Feb 25, 2021K201436Vortek Single Loop Ureteral Stent
Coloplast Corp.
FAD
Jan 2, 2020K191446Ureteral Stent Systems, Biliary Drainage Catheters
Boston Scientific Corporation
FAD
Dec 2, 2019K190659Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatri
Allwin Medical Devices, Inc.
FAD
Nov 15, 2019K190312Dornier Ureteral Stent
Dornier Medtech America, Inc.
FAD
Aug 16, 2019K191609Tria Soft Ureteral Stent
Boston Scientific Corporation
FAD
May 24, 2019K190603Tria Firm Ureteral Stent
Boston Scientific Corporation
FAD
Apr 23, 2019K181971Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
Cook Incorporated
FAD
Nov 23, 2018K180557Greene Renal Transplant Stent Set
Cook Incorporated
FAD
Nov 6, 2018K180469ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
Coloplast Corp.
FAD
Sep 28, 2018K180216Seidmon Antegrade AQ Stent Set
Cook Incorporated
FAD
Sep 21, 2018K180029Malecot Nephrostomy Catheter/Stent Set
Cook Incorporated
FAD
Sep 13, 2018K180053Sof-Flex Ureteral Stent Set
Cook Incorporated
FAD
Apr 16, 2018K171603Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
Cook Incorporated
FAD
Mar 26, 2018K172017Black Silicone Filiform Double Pigtail Stent Set
Cook Incorporated
FAD
Mar 12, 2018K173734RocaJJ Soft Stents
Promepla Sam, MC
FAD
Mar 9, 2018K180057VORTEK URETERAL DOUBLE LOOP STENT
Coloplast Corp.
FAD
Nov 15, 2017K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS
Coloplast Corp.
FAD
Nov 2, 2017K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTS
Coloplast Corp.
FAD
Oct 4, 2017K172289pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
Q Urological Corporation
FAD
Aug 28, 2017K170010Salle Intraoperative Pyeloplasty Stent Set
Cook Incorporated
FAD
Jun 22, 2017K163399Tria Firm Ureteral Stent
Boston Scientific Corporation
FAD
Jun 7, 2017K162109Kwart Retro-Inject Ureteral Stent
Cook Incorporated
FAD
Apr 24, 2017K162104C-Flex Ureteral Stent Set
Cook Incorporated
FAD
Jan 27, 2017K161236Universa Firm Ureteral Stents and Stent Sets
Cook Incorporated
FAD
Dec 22, 2016K163068pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
Q Urological Corporation
FAD
Nov 22, 2016K161277ConvertX Nephroureteral Stent System
Brightwater Medical
FAD
Jun 24, 2016K160891Ultrathane Endoureterotomy Stent Set
Cook Incorporated
FAD
Jan 11, 2016K151051Universa Soft Ureteral Stents and Stent Sets
Cook Incorporated
FAD
Oct 17, 2014K141344EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
Boston Scientific Corp
FAD
Jan 20, 2010K082805PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX
Q Urological Corporation
FAD
Aug 6, 2008K072293FOSSA URETERAL OPEN STENTS
Fossa Medical, Inc.
FAD
May 8, 2007K063742RESONANCE METALLIC URETERAL STENT
Cook Ireland, Ltd., IE
FAD
Mar 29, 2006K060673PEDIATRIC URETERAL STENT
Applied Medical Resources Corp.
FAD
Dec 30, 2004K033210BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET
Bioteque Corp.
FAD
Dec 7, 2004K043193BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
C.R. Bard, Inc.
FAD
Oct 15, 2004K040760MODIFICATION TO URETERAL STENT
Applied Medical Resources Corp.
FAD
May 22, 2003K031292MODIFICATION TO FOSSA URETERAL STONE SWEEPER
Fossa Medical, Inc.
FAD
Mar 17, 2003K030503MODIFICATION TO CONTOUR POLARIS URETERAL STENT
Boston Scientific Corp
FAD

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