COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS— 510(k) K971881

Substantially Equivalent

Comeg Endoscopy

FDA 510(k) clearance K971881 for COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS, Substantially Equivalent on 1997-08-12. Applicant: Comeg Endoscopy.

Clearance details

Applicant: Comeg Endoscopy
Product code: Code FJL
Advisory panel: Gastroenterology, Urology
Date received: 1997-05-20
Decision date: 1997-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aurora, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJL

product code FJL

Death: 2
Total: 2

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.