Clearance Summary
IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES received FDA 510(k) clearance under submission number K965055, sponsored by Imagyn Medical, 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 1997-03-06.
- Submission: K965055
- Applicant / Sponsor: Imagyn Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 1997-03-06
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.