MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000— 510(k) K912265

Substantially Equivalent

Medical Laser, Inc.

FDA 510(k) clearance K912265 for MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000, Substantially Equivalent on 1991-10-10. Applicant: Medical Laser, Inc..

Clearance details

Applicant: Medical Laser, Inc.
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 1991-05-22
Decision date: 1991-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.