NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES— 510(k) K031858
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K031858 for NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES, Substantially Equivalent on 2004-07-29. Applicant: Richard Wolf Medical Instruments Corp..
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corp.
- Product code
- Code GWG
- Advisory panel
- Neurology
- Date received
- Decision date
- 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, through . 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.