Clearance Summary
G-LIX TISSUE GRASPER received FDA 510(k) clearance under submission number K061268, sponsored by Usgi Medical. 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 2006-07-31.
- Submission: K061268
- Applicant / Sponsor: Usgi Medical
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 2006-07-31
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.