Rezum System— 510(k) K262460

Clearance details

Applicant

Boston Scientific

Product code

Code KNS

Device class

Class 2

Regulation

21 CFR 876.4300

Advisory panel

Gastroenterology, Urology

Date received

2026-07-17

Decision date

2026-09-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Marlborough, MA, US

• K260962 — Sphincterotome2026-05-21
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• K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)2025-11-25
• K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series) +3 more2025-10-17
• K250351 — Single Use Electrosurgical Knife (3 models)2025-10-10

• K253692 — AVVIGO+ Multi-Modality Guidance System2026-08-21
• K262406 — EluPro Antibiotic-Eluting BioEnvelope2026-08-12
• K260816 — OptiCross Coronary Imaging Catheter (H749518110) +7 more2026-04-08
• K252910 — Orca Air/Water and Suction Valves2025-10-09
• K251291 — Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers2025-07-03

Death

44

Injury

2,361

Malfunction

4,771

Total

7,176

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 →