Product code FAD— Gastroenterology, Urology
URETERAL STENT
- Classification name
- Stent, Ureteral
- Device class
- Class 2
- Regulation
- 21 CFR 876.4620
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 122
- First cleared
- Most recent
Market context for product code FAD
FDA has cleared devices under product code FAD between 1978 and 2026, filed by 48 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2014
- 2010
- 2008
- 2007
- 2006
Top applicants under product code FAD
Adverse events under product code FAD
product code FAD- Death
- 2
- Injury
- 858
- Malfunction
- 2,651
- Other
- 1
- Total
- 3,512
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FAD
1–100 of 122- K251890 — Disposable Ureteral Stents
- K251469 — Endura Ureteral Stent and Stent Set
- K243039 — Ureteral Stents (AF-D series)
- K243830 — Disposable ureteral stent
- K250824 — Percuflex Ureteral Stent +11 more
- K232920 — RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
- 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
- K213185 — ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits
- K213444 — RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
- K213186 — NovoFlow Reinforced Ureteral Stent
- K212868 — JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
- K200260 — Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System
- K201436 — Vortek Single Loop Ureteral Stent
- K191446 — Ureteral Stent Systems, Biliary Drainage Catheters
- 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
- K190312 — Dornier Ureteral Stent
- K191609 — Tria Soft Ureteral Stent
- K190603 — Tria Firm Ureteral Stent
- K181971 — Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
- K180557 — Greene Renal Transplant Stent Set
- K180469 — ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
- K180216 — Seidmon Antegrade AQ Stent Set
- K180029 — Malecot Nephrostomy Catheter/Stent Set
- K180053 — Sof-Flex Ureteral Stent Set
- K171603 — Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
- K172017 — Black Silicone Filiform Double Pigtail Stent Set
- K173734 — RocaJJ Soft Stents
- K180057 — VORTEK URETERAL DOUBLE LOOP STENT
- K170362 — VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS
- K170422 — BIOSOFT DUO DOUBLE LOOP URETERAL STENTS
- K172289 — pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
- K170010 — Salle Intraoperative Pyeloplasty Stent Set
- K163399 — Tria Firm Ureteral Stent
- K162109 — Kwart Retro-Inject Ureteral Stent
- K162104 — C-Flex Ureteral Stent Set
- K161236 — Universa Firm Ureteral Stents and Stent Sets
- K163068 — pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
- K161277 — ConvertX Nephroureteral Stent System
- K160891 — Ultrathane Endoureterotomy Stent Set
- K151051 — Universa Soft Ureteral Stents and Stent Sets
- K141344 — EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
- K082805 — PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX
- K072293 — FOSSA URETERAL OPEN STENTS
- K063742 — RESONANCE METALLIC URETERAL STENT
- K060673 — PEDIATRIC URETERAL STENT
- K033210 — BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET
- K043193 — BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
- K040760 — MODIFICATION TO URETERAL STENT
- K031292 — MODIFICATION TO FOSSA URETERAL STONE SWEEPER
- K030503 — MODIFICATION TO CONTOUR POLARIS URETERAL STENT
- K022447 — BARD ER URETERAL STENT WITH SUTURE
- K013921 — PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X
- K013784 — URETERAL STENT
- K021602 — FOSSA URETERAL STONE SWEEPER
- K021140 — FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT
- K011264 — MESH URETERAL STENT
- K010002 — CONTOUR POLARIS URETERAL STENT
- K992391 — UROSURGE SPIRALFLO URETERAL STENT
- K982974 — DD URETERAL STENT, INTEGRAL STENT
- K991219 — C-FLEX URETERAL STENTS
- K983498 — BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE
- K981591 — VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
- K981489 — UROSURGE SPIRASTENT PLUS URETERAL STENT
- K981491 — UROSURGE FILASTENT URETERAL STENT
- K974541 — MODIFIED URETERAL INDWELLING CATHETER/STENT
- K973504 — UROSURGE UROSTENT
- K961371 — SUBCUTANEOUS URINARY DIVERSON STENT SET
- K952513 — LESE STENTS SETS
- K961446 — AQ HYDROPHILIC STENT
- K960148 — CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT
- K946296 — QUADRA-COIL URETERAL STENT
- K930731 — SLIP-COAT STENTS
- K941952 — SURGITEK INFUSER
- K933941 — MENLO CARE URINARY DIVERSION STENT
- K923394 — MENLO CARE AQUASTENT SET
- K930733 — URETERAL STENT
- K930882 — UROLOGICAL CATHETER & ACCESSORIES
- K925282 — UROLOGICAL CATHETER AND ACCESSORIES
- K920695 — URETERAL STENT
- K914280 — ECHOSIGHT STENT SET
- K913928 — SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT
- K912060 — MENTOR BLACK LIGHT INJECTION STENT SET
- K910691 — NORTEC URETERAL STENT
- K903345 — BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE
- K905505 — VAS-CATH URETERAL STENTS CATHETER, MODIFICATION
- K905289 — SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT
- K904231 — MODEL OSP, SANDHILL AMS
- K894357 — VAS-CATH URETERAL STENT CATHETER
- K883561 — BARD(R) URETERAL STENT W/SUTURE
- K882157 — PANAMEX(TM) URETERAL STENT
- K881744 — PORGES URETERAL STENT
- K880660 — SURGITEK SUPER DOUBLE J URETERAL STENT KIT
- K875038 — MENTOR UNISTENT URETERAL STENT SET
- K873557 — MENTOR BLACK LIGHT URETERAL STENT SET
- K872353 — SURGITEK INFUSION STENT SYSTEM*
- K871667 — URETERAL STENT
- K871291 — AM CATH ESWL STENT
- K865085 — KAMINSKY COMBINATION STENT & INJECTION CATHETER
- K864225 — ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT
- K864669 — AM CATH ESWL STENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.