Clearance Summary
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 received FDA 510(k) clearance under submission number K092278, sponsored by Gyrus Acmi, Inc.. 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 2009-09-29.
- Submission: K092278
- Applicant / Sponsor: Gyrus Acmi, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1690
- Decision date: 2009-09-29
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.