K031858

Substantially Equivalent

NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES

Applicant: Richard Wolf Medical Instruments Corp.
Product code: GWG
Advisory panel: Neurology
Date received: 2003-06-16
Decision date: 2004-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.