FDA 510(k) Applications for Medical Device Product Code "FAD"
(Stent, Ureteral)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K190659 | Allwin Medical Devices, Inc. | 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/Cl | 12/02/2019 |
| K991219 | APPLIED MEDICAL RESOURCES | C-FLEX URETERAL STENTS | 06/21/1999 |
| K011264 | APPLIED MEDICAL RESOURCES CORP. | MESH URETERAL STENT | 07/17/2001 |
| K040760 | APPLIED MEDICAL RESOURCES CORP. | MODIFICATION TO URETERAL STENT | 10/15/2004 |
| K060673 | APPLIED MEDICAL RESOURCES CORP. | PEDIATRIC URETERAL STENT | 03/29/2006 |
| K033210 | BIOTEQUE CORP. | BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET | 12/30/2004 |
| K010002 | BOSTON SCIENTIFIC CORP. | CONTOUR POLARIS URETERAL STENT | 01/22/2001 |
| K141344 | BOSTON SCIENTIFIC CORP. | EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM | 10/17/2014 |
| K030503 | BOSTON SCIENTIFIC CORP. | MODIFICATION TO CONTOUR POLARIS URETERAL STENT | 03/17/2003 |
| K974541 | BOSTON SCIENTIFIC CORP. | MODIFIED URETERAL INDWELLING CATHETER/STENT | 02/09/1998 |
| K013784 | BOSTON SCIENTIFIC CORP. | URETERAL STENT | 08/08/2002 |
| K211934 | Boston Scientific Corporation | 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 Cath | 11/10/2022 |
| K200260 | Boston Scientific Corporation | Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System | 04/26/2021 |
| K163399 | Boston Scientific Corporation | Tria Firm Ureteral Stent | 06/22/2017 |
| K190603 | Boston Scientific Corporation | Tria Firm Ureteral Stent | 05/24/2019 |
| K191609 | Boston Scientific Corporation | Tria Soft Ureteral Stent | 08/16/2019 |
| K191446 | Boston Scientific Corporation | Ureteral Stent Systems, Biliary Drainage Catheters | 01/02/2020 |
| K161277 | BRIGHTWATER MEDICAL | ConvertX Nephroureteral Stent System | 11/22/2016 |
| K022447 | C.R. BARD, INC. | BARD ER URETERAL STENT WITH SUTURE | 01/23/2003 |
| K983498 | C.R. BARD, INC. | BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE | 12/15/1998 |
| K043193 | C.R. BARD, INC. | BARD INLAYOPTIMA URETERAL STENT WITH SUTURE | 12/07/2004 |
| K960148 | CABOT MEDICAL CORP. | CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT | 03/25/1996 |
| K170422 | Coloplast Corp | BIOSOFT DUO DOUBLE LOOP URETERAL STENTS | 11/02/2017 |
| K213185 | Coloplast Corp | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits | 06/08/2022 |
| K180469 | Coloplast Corp | ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent | 11/06/2018 |
| K213186 | Coloplast Corp | NovoFlow Reinforced Ureteral Stent | 02/16/2022 |
| K170362 | Coloplast Corp | VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS | 11/15/2017 |
| K201436 | Coloplast Corp | Vortek Single Loop Ureteral Stent | 02/25/2021 |
| K180057 | Coloplast Corp | VORTEK URETERAL DOUBLE LOOP STENT | 03/09/2018 |
| K181971 | Cook Incorporated | Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set | 04/23/2019 |
| K172017 | Cook Incorporated | Black Silicone Filiform Double Pigtail Stent Set | 03/26/2018 |
| K162104 | COOK INCORPORATED | C-Flex Ureteral Stent Set | 04/24/2017 |
| K171603 | Cook Incorporated | Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set | 04/16/2018 |
| K180557 | Cook Incorporated | Greene Renal Transplant Stent Set | 11/23/2018 |
| K162109 | COOK INCORPORATED | Kwart Retro-Inject Ureteral Stent | 06/07/2017 |
| K180029 | Cook Incorporated | Malecot Nephrostomy Catheter/Stent Set | 09/21/2018 |
| K170010 | COOK INCORPORATED | Salle Intraoperative Pyeloplasty Stent Set | 08/28/2017 |
| K180216 | Cook Incorporated | Seidmon Antegrade AQ Stent Set | 09/28/2018 |
| K180053 | Cook Incorporated | Sof-Flex Ureteral Stent Set | 09/13/2018 |
| K160891 | Cook Incorporated | Ultrathane Endoureterotomy Stent Set | 06/24/2016 |
| K161236 | COOK INCORPORATED | Universa Firm Ureteral Stents and Stent Sets | 01/27/2017 |
| K151051 | COOK INCORPORATED | Universa Soft Ureteral Stents and Stent Sets | 01/11/2016 |
| K063742 | COOK IRELAND LTD | RESONANCE METALLIC URETERAL STENT | 05/08/2007 |
| K961446 | COOK UROLOGICAL, INC. | AQ HYDROPHILIC STENT | 05/28/1996 |
| K952513 | COOK UROLOGICAL, INC. | LESE STENTS SETS | 06/10/1996 |
| K961371 | COOK UROLOGICAL, INC. | SUBCUTANEOUS URINARY DIVERSON STENT SET | 07/24/1996 |
| K190312 | Dornier MedTech America Inc. | Dornier Ureteral Stent | 11/15/2019 |
| K021140 | FOSSA INDUSTRIES, INC. | FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT | 06/28/2002 |
| K021602 | FOSSA INDUSTRIES, INC. | FOSSA URETERAL STONE SWEEPER | 07/26/2002 |
| K072293 | FOSSA MEDICAL, INC. | FOSSA URETERAL OPEN STENTS | 08/06/2008 |
| K031292 | FOSSA MEDICAL, INC. | MODIFICATION TO FOSSA URETERAL STONE SWEEPER | 05/22/2003 |
| K981591 | INTERNATIONAL REGULATORY CONSULTANTS | VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT | 10/09/1998 |
| K013921 | PORGES S.A. | PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X | 10/17/2002 |
| K973504 | PRINCETON REGULATORY ASSOC. | UROSURGE UROSTENT | 01/30/1998 |
| K173734 | Promepla SAM | RocaJJ Soft Stents | 03/12/2018 |
| K163068 | Q UROLOGICAL CORPORATION | pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent | 12/22/2016 |
| K172289 | Q Urological Corporation | pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent | 10/04/2017 |
| K082805 | Q UROLOGICAL CORPORATION | PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX | 01/20/2010 |
| K212868 | Rocamed SAM | JFil Ureteral Stents, JFil Ureteral Stents ECO KIT | 01/26/2022 |
| K982974 | RUSCH INTL. | DD URETERAL STENT, INTEGRAL STENT | 07/02/1999 |
| K213444 | Ureteral Stent Company | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm | 03/17/2022 |
| K981491 | UROSURGE, INC. | UROSURGE FILASTENT URETERAL STENT | 05/29/1998 |
| K992391 | UROSURGE, INC. | UROSURGE SPIRALFLO URETERAL STENT | 08/18/1999 |
| K981489 | UROSURGE, INC. | UROSURGE SPIRASTENT PLUS URETERAL STENT | 05/29/1998 |
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