Clearance Summary
NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES received FDA 510(k) clearance under submission number K953554, sponsored by Nobles-Lai Engineering, 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 1995-10-18.
- Submission: K953554
- Applicant / Sponsor: Nobles-Lai Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1480
- Decision date: 1995-10-18
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.