510(k) K912447— SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200

Substantially Equivalent

Medical Laser, Inc.

Clearance details

Applicant: Medical Laser, Inc.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 1991-06-03
Decision date: 1991-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.