Clearance Summary
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) received FDA 510(k) clearance under submission number K111059, 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 2011-09-01.
- Submission: K111059
- Applicant / Sponsor: Gyrus Acmi, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4150
- Decision date: 2011-09-01
Classification & Regulation
This clearance is catalogued under FDA product code HIN and 21 CFR 884.4150, within the Obstetrics/Gynecology review panel as a Class II device.