Percuflex Ureteral Stent +11 more— 510(k) K250824

Clearance details

Device name as filed

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

Applicant

Boston Scientific Corporation

Product code

Code FAD

Device class

Class 2

Regulation

21 CFR 876.4620

Advisory panel

Gastroenterology, Urology

Date received

2025-03-18

Decision date

2025-04-15

Decision

Substantially Equivalent

Clearance type

Special

Location

Marlborough, MA, US

• K251890 — Disposable Ureteral Stents2026-02-20
• K251469 — Endura Ureteral Stent and Stent Set2025-12-19
• K243039 — Ureteral Stents (AF-D series)2025-06-18
• K243830 — Disposable ureteral stent2025-05-14
• K232920 — RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm2024-03-22

• K262151 — SpaceOAR Flex System2026-09-11
• K261153 — LithoVue Elite Digital Flexible Ureteroscope System2026-08-26
• K261915 — Navigator Flex Ureteral Access Sheath Set2026-08-04
• K261488 — OBSIDIO Conformable Embolic2026-07-24
• K262165 — FARADRIVE Steerable Sheath (M004PF21M402)2026-07-24

Death

2

Injury

858

Malfunction

2,651

Other

1

Total

3,512

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →