Clearance Summary
HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES received FDA 510(k) clearance under submission number K931764, sponsored by Olympus Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1994-06-08.
- Submission: K931764
- Applicant / Sponsor: Olympus Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1690
- Decision date: 1994-06-08
Classification & Regulation
This clearance is catalogued under FDA product code HIH and 21 CFR 884.1690, within the Obstetrics/Gynecology review panel as a Class II device.