Clearance Summary
GYRUS HYSTEROSCOPIC RESECTOSCOPE received FDA 510(k) clearance under submission number K982771, sponsored by Gyrus Medical , Ltd.. 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 1999-01-21.
- Submission: K982771
- Applicant / Sponsor: Gyrus Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1690
- Decision date: 1999-01-21
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.