FDA Product Code
FDA Product Code FAD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4620
510(k) Clearances — 122 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251890 | Disposable Ureteral Stents | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-02-20 | Traditional | PDF ↗ |
| K251469 | Endura Ureteral Stent and Stent Set | Cathegenix (Xiamen) Co., Ltd. | 2025-12-19 | Traditional | PDF ↗ |
| K243039 | Ureteral Stents (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-06-18 | Traditional | PDF ↗ |
| K243830 | Disposable ureteral stent | Shenzhen Trious Medical Technology Co., Ltd. | 2025-05-14 | Traditional | PDF ↗ |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set | Boston Scientific Corporation | 2025-04-15 | Special | PDF ↗ |
| K232920 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm | Ureteral Stent Company | 2024-03-22 | Traditional | PDF ↗ |
| K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg | Boston Scientific Corporation | 2022-11-10 | Traditional | PDF ↗ |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits | Coloplast Corp. | 2022-06-08 | Traditional | PDF ↗ |
| K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm | Ureteral Stent Company | 2022-03-17 | Traditional | PDF ↗ |
| K213186 | NovoFlow Reinforced Ureteral Stent | Coloplast Corp. | 2022-02-16 | Traditional | PDF ↗ |
| K212868 | JFil Ureteral Stents, JFil Ureteral Stents ECO KIT | Rocamed Sam | 2022-01-26 | Traditional | PDF ↗ |
| K200260 | Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System | Boston Scientific Corporation | 2021-04-26 | Traditional | PDF ↗ |
| K201436 | Vortek Single Loop Ureteral Stent | Coloplast Corp. | 2021-02-25 | Traditional | PDF ↗ |
| K191446 | Ureteral Stent Systems, Biliary Drainage Catheters | Boston Scientific Corporation | 2020-01-02 | Traditional | PDF ↗ |
| K190659 | Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip | Allwin Medical Devices, Inc. | 2019-12-02 | Traditional | PDF ↗ |
| K190312 | Dornier Ureteral Stent | Dornier Medtech America, Inc. | 2019-11-15 | Traditional | PDF ↗ |
| K191609 | Tria Soft Ureteral Stent | Boston Scientific Corporation | 2019-08-16 | Traditional | PDF ↗ |
| K190603 | Tria Firm Ureteral Stent | Boston Scientific Corporation | 2019-05-24 | Special | PDF ↗ |
| K181971 | Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set | Cook Incorporated | 2019-04-23 | Traditional | PDF ↗ |
| K180557 | Greene Renal Transplant Stent Set | Cook Incorporated | 2018-11-23 | Traditional | PDF ↗ |
| K180469 | ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent | Coloplast Corp. | 2018-11-06 | Traditional | PDF ↗ |
| K180216 | Seidmon Antegrade AQ Stent Set | Cook Incorporated | 2018-09-28 | Traditional | PDF ↗ |
| K180029 | Malecot Nephrostomy Catheter/Stent Set | Cook Incorporated | 2018-09-21 | Traditional | PDF ↗ |
| K180053 | Sof-Flex Ureteral Stent Set | Cook Incorporated | 2018-09-13 | Traditional | PDF ↗ |
| K171603 | Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set | Cook Incorporated | 2018-04-16 | Traditional | PDF ↗ |
| K172017 | Black Silicone Filiform Double Pigtail Stent Set | Cook Incorporated | 2018-03-26 | Traditional | PDF ↗ |
| K173734 | RocaJJ Soft Stents | Promepla Sam | 2018-03-12 | Traditional | PDF ↗ |
| K180057 | VORTEK URETERAL DOUBLE LOOP STENT | Coloplast Corp. | 2018-03-09 | Traditional | PDF ↗ |
| K170362 | VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS | Coloplast Corp. | 2017-11-15 | Traditional | PDF ↗ |
| K170422 | BIOSOFT DUO DOUBLE LOOP URETERAL STENTS | Coloplast Corp. | 2017-11-02 | Traditional | PDF ↗ |
| K172289 | pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent | Q Urological Corporation | 2017-10-04 | Special | PDF ↗ |
| K170010 | Salle Intraoperative Pyeloplasty Stent Set | Cook Incorporated | 2017-08-28 | Traditional | PDF ↗ |
| K163399 | Tria Firm Ureteral Stent | Boston Scientific Corporation | 2017-06-22 | Traditional | PDF ↗ |
| K162109 | Kwart Retro-Inject Ureteral Stent | Cook Incorporated | 2017-06-07 | Traditional | PDF ↗ |
| K162104 | C-Flex Ureteral Stent Set | Cook Incorporated | 2017-04-24 | Traditional | PDF ↗ |
| K161236 | Universa Firm Ureteral Stents and Stent Sets | Cook Incorporated | 2017-01-27 | Traditional | PDF ↗ |
| K163068 | pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent | Q Urological Corporation | 2016-12-22 | Special | PDF ↗ |
| K161277 | ConvertX Nephroureteral Stent System | Brightwater Medical | 2016-11-22 | Traditional | PDF ↗ |
| K160891 | Ultrathane Endoureterotomy Stent Set | Cook Incorporated | 2016-06-24 | Traditional | PDF ↗ |
| K151051 | Universa Soft Ureteral Stents and Stent Sets | Cook Incorporated | 2016-01-11 | Traditional | PDF ↗ |
| K141344 | EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM | Boston Scientific Corp | 2014-10-17 | Traditional | PDF ↗ |
| K082805 | PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX | Q Urological Corporation | 2010-01-20 | Traditional | PDF ↗ |
| K072293 | FOSSA URETERAL OPEN STENTS | Fossa Medical, Inc. | 2008-08-06 | Traditional | PDF ↗ |
| K063742 | RESONANCE METALLIC URETERAL STENT | Cook Ireland, Ltd. | 2007-05-08 | Traditional | PDF ↗ |
| K060673 | PEDIATRIC URETERAL STENT | Applied Medical Resources Corp. | 2006-03-29 | Traditional | PDF ↗ |
| K033210 | BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET | Bioteque Corp. | 2004-12-30 | Traditional | PDF ↗ |
| K043193 | BARD INLAYOPTIMA URETERAL STENT WITH SUTURE | C.R. Bard, Inc. | 2004-12-07 | Special | PDF ↗ |
| K040760 | MODIFICATION TO URETERAL STENT | Applied Medical Resources Corp. | 2004-10-15 | Special | PDF ↗ |
| K031292 | MODIFICATION TO FOSSA URETERAL STONE SWEEPER | Fossa Medical, Inc. | 2003-05-22 | Special | PDF ↗ |
| K030503 | MODIFICATION TO CONTOUR POLARIS URETERAL STENT | Boston Scientific Corp | 2003-03-17 | Special | PDF ↗ |
| K022447 | BARD ER URETERAL STENT WITH SUTURE | C.R. Bard, Inc. | 2003-01-23 | Traditional | PDF ↗ |
| K013921 | PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X | Porges S.A. | 2002-10-17 | Traditional | PDF ↗ |
| K013784 | URETERAL STENT | Boston Scientific Corp | 2002-08-08 | Traditional | PDF ↗ |
| K021602 | FOSSA URETERAL STONE SWEEPER | Fossa Industries, Inc. | 2002-07-26 | Traditional | PDF ↗ |
| K021140 | FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT | Fossa Industries, Inc. | 2002-06-28 | Traditional | PDF ↗ |
| K011264 | MESH URETERAL STENT | Applied Medical Resources Corp. | 2001-07-17 | Traditional | PDF ↗ |
| K010002 | CONTOUR POLARIS URETERAL STENT | Boston Scientific Corp | 2001-01-22 | Special | PDF ↗ |
| K992391 | UROSURGE SPIRALFLO URETERAL STENT | Urosurge, Inc. | 1999-08-18 | Traditional | PDF ↗ |
| K982974 | DD URETERAL STENT, INTEGRAL STENT | Rusch Intl. | 1999-07-02 | Traditional | PDF ↗ |
| K991219 | C-FLEX URETERAL STENTS | Applied Medical Resources | 1999-06-21 | Traditional | PDF ↗ |
| K983498 | BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE | C.R. Bard, Inc. | 1998-12-15 | Abbreviated | PDF ↗ |
| K981591 | VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT | International Regulatory Consultants | 1998-10-09 | Special | PDF ↗ |
| K981489 | UROSURGE SPIRASTENT PLUS URETERAL STENT | Urosurge, Inc. | 1998-05-29 | Traditional | PDF ↗ |
| K981491 | UROSURGE FILASTENT URETERAL STENT | Urosurge, Inc. | 1998-05-29 | Traditional | PDF ↗ |
| K974541 | MODIFIED URETERAL INDWELLING CATHETER/STENT | Boston Scientific Corp | 1998-02-09 | Traditional | PDF ↗ |
| K973504 | UROSURGE UROSTENT | Princeton Regulatory Assoc. | 1998-01-30 | Traditional | PDF ↗ |
| K961371 | SUBCUTANEOUS URINARY DIVERSON STENT SET | Cook Urological, Inc. | 1996-07-24 | Traditional | PDF ↗ |
| K952513 | LESE STENTS SETS | Cook Urological, Inc. | 1996-06-10 | Traditional | PDF ↗ |
| K961446 | AQ HYDROPHILIC STENT | Cook Urological, Inc. | 1996-05-28 | Traditional | PDF ↗ |
| K960148 | CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT | Cabot Medical Corp. | 1996-03-25 | Traditional | PDF ↗ |
| K946296 | QUADRA-COIL URETERAL STENT | Surgitek | 1995-03-06 | Traditional | PDF ↗ |
| K930731 | SLIP-COAT STENTS | Cook Urological, Inc. | 1994-12-08 | Traditional | PDF ↗ |
| K941952 | SURGITEK INFUSER | Surgitek | 1994-05-24 | Traditional | PDF ↗ |
| K933941 | MENLO CARE URINARY DIVERSION STENT | Menlo Care, Inc. | 1994-03-31 | Traditional | PDF ↗ |
| K923394 | MENLO CARE AQUASTENT SET | Menlo Care, Inc. | 1993-11-16 | Traditional | PDF ↗ |
| K930733 | URETERAL STENT | Surgitek | 1993-07-23 | Traditional | PDF ↗ |
| K930882 | UROLOGICAL CATHETER & ACCESSORIES | Applied Medical Resources | 1993-07-08 | Traditional | PDF ↗ |
| K925282 | UROLOGICAL CATHETER AND ACCESSORIES | Applied Urology, Inc. | 1993-01-13 | Traditional | PDF ↗ |
| K920695 | URETERAL STENT | Applied Urology, Inc. | 1992-09-23 | Traditional | PDF ↗ |
| K914280 | ECHOSIGHT STENT SET | Cook Urological, Inc. | 1992-01-09 | Traditional | PDF ↗ |
| K913928 | SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT | Surgitek Medical Engineering Corp. | 1991-11-19 | Traditional | PDF ↗ |
| K912060 | MENTOR BLACK LIGHT INJECTION STENT SET | Mentor Corp. | 1991-09-27 | Traditional | PDF ↗ |
| K910691 | NORTEC URETERAL STENT | North American Sterilization & Packaging Co. | 1991-08-15 | Traditional | PDF ↗ |
| K903345 | BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE | C.R. Bard, Inc. | 1991-04-30 | Traditional | PDF ↗ |
| K905505 | VAS-CATH URETERAL STENTS CATHETER, MODIFICATION | Vas-Cath, Inc. | 1991-04-09 | Traditional | PDF ↗ |
| K905289 | SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT | Medical Engineering Corp. | 1991-03-13 | Traditional | PDF ↗ |
| K904231 | MODEL OSP, SANDHILL AMS | Sandhill Scientific, Inc. | 1991-01-02 | Traditional | PDF ↗ |
| K894357 | VAS-CATH URETERAL STENT CATHETER | Vas-Cath, Inc. | 1989-10-03 | Traditional | PDF ↗ |
| K883561 | BARD(R) URETERAL STENT W/SUTURE | C.R. Bard, Inc. | 1988-11-15 | Traditional | PDF ↗ |
| K882157 | PANAMEX(TM) URETERAL STENT | Kingston Technologies, Inc. | 1988-08-02 | Traditional | PDF ↗ |
| K881744 | PORGES URETERAL STENT | Bivona Medical Technologies | 1988-05-03 | Traditional | PDF ↗ |
| K880660 | SURGITEK SUPER DOUBLE J URETERAL STENT KIT | Surgitek | 1988-04-14 | Traditional | PDF ↗ |
| K875038 | MENTOR UNISTENT URETERAL STENT SET | Mentor Corp. | 1988-03-03 | Traditional | PDF ↗ |
| K873557 | MENTOR BLACK LIGHT URETERAL STENT SET | Mentor Corp. | 1988-02-11 | Traditional | PDF ↗ |
| K872353 | SURGITEK INFUSION STENT SYSTEM* | Surgitek | 1987-09-16 | Traditional | PDF ↗ |
| K871667 | URETERAL STENT | Penn Medical Devices, Inc. | 1987-06-10 | Traditional | PDF ↗ |
| K871291 | AM CATH ESWL STENT | Inter-Med Corp. | 1987-04-30 | Traditional | PDF ↗ |
| K865085 | KAMINSKY COMBINATION STENT & INJECTION CATHETER | Van-Tec, Inc. | 1987-03-25 | Traditional | PDF ↗ |
| K864225 | ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT | Angiomed U.S., Inc. | 1987-01-30 | Traditional | PDF ↗ |
| K864669 | AM CATH ESWL STENT | Inter-Med Corp. | 1987-01-05 | Traditional | PDF ↗ |
Product code FAD · Class II · Gastroenterology, Urology. Data: openFDA.