Clearance Summary
KSEA NEURO-FIBERSCOPE received FDA 510(k) clearance under submission number K991069, sponsored by KARL STORZ Endoscopy-America, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1999-06-03.
- Submission: K991069
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1480
- Decision date: 1999-06-03
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.