MEDILASE SERIES 2200 ENDOSCOPE— 510(k) K901464

Substantially Equivalent

Medical Laser, Inc.

FDA 510(k) clearance K901464 for MEDILASE SERIES 2200 ENDOSCOPE, Substantially Equivalent on 1990-08-07. Applicant: Medical Laser, Inc..

Clearance details

Applicant: Medical Laser, Inc.
Product code: Code GCM
Advisory panel: Gastroenterology, Urology
Date received: 1990-03-28
Decision date: 1990-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCM

product code GCM

Malfunction: 1,233
Total: 1,233

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.