Clearance Summary
CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 received FDA 510(k) clearance under submission number K980588, sponsored by Clarus Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1998-08-18.
- Submission: K980588
- Applicant / Sponsor: Clarus Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1998-08-18
Classification & Regulation
This clearance is catalogued under FDA product code GAD and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.