FAD — Stent, Ureteral Class II
FDA product code FAD covers "Stent, Ureteral", a Class II medical device regulated under 21 CFR 876.4620. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FAD
- Device Class
- Class II
- Regulation Number
- 876.4620
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251890 | zhejiang chuangxiang medical technology co | Disposable Ureteral Stents | February 20, 2026 |
| K251469 | cathegenix (xiamen) co | Endura Ureteral Stent and Stent Set | December 19, 2025 |
| K243039 | alton (shanghai) medical instruments co | Ureteral Stents (AF-D series) | June 18, 2025 |
| K243830 | shenzhen trious medical technology co | Disposable ureteral stent | May 14, 2025 |
| K250824 | boston scientific corporation | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDriv | April 15, 2025 |
| K232920 | ureteral stent | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent | March 22, 2024 |
| K211934 | boston scientific corporation | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima AP | November 10, 2022 |
| K213185 | coloplast | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone doub | June 8, 2022 |
| K213444 | ureteral stent | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Ki | March 17, 2022 |
| K213186 | coloplast | NovoFlow Reinforced Ureteral Stent | February 16, 2022 |
| K212868 | rocamed sam | JFil Ureteral Stents, JFil Ureteral Stents ECO KIT | January 26, 2022 |
| K200260 | boston scientific corporation | Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex | April 26, 2021 |
| K201436 | coloplast | Vortek Single Loop Ureteral Stent | February 25, 2021 |
| K191446 | boston scientific corporation | Ureteral Stent Systems, Biliary Drainage Catheters | January 2, 2020 |
| K190659 | allwin medical devices | Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureter | December 2, 2019 |
| K190312 | dornier medtech america | Dornier Ureteral Stent | November 15, 2019 |
| K191609 | boston scientific corporation | Tria Soft Ureteral Stent | August 16, 2019 |
| K190603 | boston scientific corporation | Tria Firm Ureteral Stent | May 24, 2019 |
| K181971 | cook incorporated | Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set | April 23, 2019 |
| K180557 | cook incorporated | Greene Renal Transplant Stent Set | November 23, 2018 |