Clearance Summary
IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER received FDA 510(k) clearance under submission number K971255, 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 1997-04-21.
- Submission: K971255
- Applicant / Sponsor: Imagyn Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 1997-04-21
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.