510(k) K950417— EPX-310 VIDEO PROCESSOR (ENDOSCOPY)

Substantially Equivalent

Marks & Murase

Clearance details

Applicant: Marks & Murase
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 1995-01-31
Decision date: 1995-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.