Clearance Summary
OLYMPUS HX-20 SERIES LIGATING DEVICE received FDA 510(k) clearance under submission number K984255, sponsored by Olympus Corp of America. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1999-01-12.
- Submission: K984255
- Applicant / Sponsor: Olympus Corp of America
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4400
- Decision date: 1999-01-12
Classification & Regulation
This clearance is catalogued under FDA product code MND and 21 CFR 876.4400, within the Gastroenterology, Urology review panel as a Class II device.