Clearance Summary
GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS received FDA 510(k) clearance under submission number K942544, sponsored by Medi-Globe Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1994-11-22.
- Submission: K942544
- Applicant / Sponsor: Medi-Globe Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4500
- Decision date: 1994-11-22
Classification & Regulation
This clearance is catalogued under FDA product code LQC and 21 CFR 876.4500, within the Gastroenterology, Urology review panel as a Class II device.