FAD · Class II · 21 CFR 876.4620

FDA Product Code FAD: Stent, Ureteral

Under FDA product code FAD, ureteral stents are cleared for maintaining ureteral patency in patients with obstruction or following urological procedures.

These flexible double-J or double-pigtail devices are placed endoscopically to bridge a ureteral obstruction or hold the ureter open after stone treatment, surgery, or trauma. They allow urine to flow from the kidney to the bladder while the underlying condition is treated.

FAD devices are Class II medical devices, regulated under 21 CFR 876.4620 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Cook Incorporated, Boston Scientific Corporation and C.R. Bard, Inc..

122
Total
122
Cleared
154d
Avg days
1978
Since
Growing category - 5 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 182d recently vs 153d historically

FDA 510(k) Cleared Stent, Ureteral Devices (Product Code FAD)

122 devices
1–24 of 122
Cleared Feb 20, 2026
Disposable Ureteral Stents
K251890
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Gastroenterology & Urology · 245d
Cleared Dec 19, 2025
Endura™ Ureteral Stent and Stent Set
K251469
Cathegenix (Xiamen) Co., Ltd.
Gastroenterology & Urology · 220d
Cleared Jun 18, 2025
Ureteral Stents (AF-D series)
K243039
Alton (Shanghai) Medical Instruments Co., Ltd.
Gastroenterology & Urology · 264d
Cleared May 14, 2025
Disposable ureteral stent
K243830
Shenzhen Trious Medical Technology Co., Ltd.
Gastroenterology & Urology · 152d
Cleared Apr 15, 2025
Percuflex Ureteral Stent
K250824
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Mar 22, 2024
RELIEF™ Ureteral Stent Kit
K232920
Ureteral Stent Company
Gastroenterology & Urology · 185d
Cleared Nov 10, 2022
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
K211934
Boston Scientific Corporation
Gastroenterology & Urology · 506d
Cleared Jun 08, 2022
ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits
K213185
Coloplast Corp.
Gastroenterology & Urology · 252d
Cleared Mar 17, 2022
RELIEF Ureteral Stent Kit
K213444
Ureteral Stent Company
Gastroenterology & Urology · 143d
Cleared Feb 16, 2022
NovoFlow Reinforced Ureteral Stent
K213186
Coloplast Corp.
Gastroenterology & Urology · 140d
Cleared Jan 26, 2022
JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
K212868
Rocamed Sam
Gastroenterology & Urology · 139d
Cleared Apr 26, 2021
Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System
K200260
Boston Scientific Corporation
Gastroenterology & Urology · 448d
Cleared Feb 25, 2021
Vortek Single Loop Ureteral Stent
K201436
Coloplast Corp.
Gastroenterology & Urology · 269d
Cleared Jan 02, 2020
Ureteral Stent Systems, Biliary Drainage Catheters
K191446
Boston Scientific Corporation
Gastroenterology & Urology · 216d
Cleared Dec 02, 2019
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
K190659
Allwin Medical Devices, Inc.
Gastroenterology & Urology · 263d
Cleared Nov 15, 2019
Dornier Ureteral Stent
K190312
Dornier Medtech America, Inc.
Gastroenterology & Urology · 276d
Cleared Aug 16, 2019
Tria Soft Ureteral Stent
K191609
Boston Scientific Corporation
Gastroenterology & Urology · 60d
Cleared May 24, 2019
Tria Firm Ureteral Stent
K190603
Boston Scientific Corporation
Gastroenterology & Urology · 77d
Cleared Apr 23, 2019
Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
K181971
Cook Incorporated
Gastroenterology & Urology · 273d
Cleared Nov 23, 2018
Greene Renal Transplant Stent Set
K180557
Cook Incorporated
Gastroenterology & Urology · 267d
Cleared Nov 06, 2018
ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
K180469
Coloplast Corp.
Gastroenterology & Urology · 258d
Cleared Sep 28, 2018
Seidmon Antegrade AQ Stent Set
K180216
Cook Incorporated
Gastroenterology & Urology · 246d
Cleared Sep 21, 2018
Malecot Nephrostomy Catheter/Stent Set
K180029
Cook Incorporated
Gastroenterology & Urology · 261d
Cleared Sep 13, 2018
Sof-Flex Ureteral Stent Set
K180053
Cook Incorporated
Gastroenterology & Urology · 248d

About Product Code FAD - Regulatory Context

510(k) Submission Activity

122 total 510(k) submissions under product code FAD since 1978, with 122 receiving FDA clearance (average review time: 154 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FAD Product Code

Recent submissions under FAD have taken an average of 182 days to reach a decision - up from 153 days historically. Manufacturers should account for longer review timelines in current project planning.

FAD devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →