System 83 Revolve Endoscope Washer/Disinfector— 510(k) K241168

Name: FDA 510(k) clearance K241168
Creator: U.S. Food and Drug Administration
Published: 2024-12-19

Substantially Equivalent

Wassenburg Medical, Inc.

FDA 510(k) clearance K241168 for System 83 Revolve Endoscope Washer/Disinfector, Substantially Equivalent on 2024-12-19. Applicant: Wassenburg Medical, Inc.. Device class: 2.

Clearance details

Applicant: Wassenburg Medical, Inc.
Product code: Code FEB
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2024-04-26
Decision date: 2024-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ivyland, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.