Clearance Summary
MSS-28CS-301/701 NEEDLESCOPE received FDA 510(k) clearance under submission number K013759, sponsored by Olympus Optical Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2002-08-20.
- Submission: K013759
- Applicant / Sponsor: Olympus Optical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1480
- Decision date: 2002-08-20
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.