Clearance Summary
NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES received FDA 510(k) clearance under submission number K031858, sponsored by Richard Wolf Medical Instruments Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2004-07-29.
- Submission: K031858
- Applicant / Sponsor: Richard Wolf Medical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1480
- Decision date: 2004-07-29
Classification & Regulation
This clearance is catalogued under FDA product code GWG and 21 CFR 882.1480, within the Neurology review panel as a Class II device.