Clearance Summary
GIP/MEDI-GLOBE PAPILLOTOME received FDA 510(k) clearance under submission number K943629, 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 1995-05-26.
- Submission: K943629
- Applicant / Sponsor: Medi-Globe Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 1995-05-26
Classification & Regulation
This clearance is catalogued under FDA product code KNS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.