Clearance Summary
KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS received FDA 510(k) clearance under submission number K982837, sponsored by Karl Storz Endoscopy. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1998-11-06.
- Submission: K982837
- Applicant / Sponsor: Karl Storz Endoscopy
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1480
- Decision date: 1998-11-06
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.