Clearance Summary
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA received FDA 510(k) clearance under submission number K022270, sponsored by Olympus Optical Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2002-08-14.
- Submission: K022270
- Applicant / Sponsor: Olympus Optical Co., Ltd.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2002-08-14
Classification & Regulation
This clearance is catalogued under FDA product code ODA and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.