510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250584Substantially Equivalent

Rezum System

Boston Scientific Corporation, Marlboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250584 is the FDA 510(k) clearance record for Rezum System, a class II device, cleared for Boston Scientific Corporation on under FDA product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K250584.

Clearance record

Decision date
Received
(104 days to decision)
Product code
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corporation 100 Boston Scientific Way, Marlboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNS

Trailing 12 months
4 clearances under product code KNS in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KNS, trailing twelve months
MonthClearances
November 20252
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260