Clearance Summary
CASPAR SCALP CLIP, APPLIER received FDA 510(k) clearance under submission number K890443, sponsored by Aesculap 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 1989-06-15.
- Submission: K890443
- Applicant / Sponsor: Aesculap Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4150
- Decision date: 1989-06-15
Classification & Regulation
This clearance is catalogued under FDA product code HBO and 21 CFR 882.4150, within the Neurology review panel as a Class II device.