MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM— 510(k) K092387

Substantially Equivalent

Minntech Corp.

FDA 510(k) clearance K092387 for MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM, Substantially Equivalent on 2010-04-05. Applicant: Minntech Corp..

Clearance details

Applicant: Minntech Corp.
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 2009-08-05
Decision date: 2010-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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.