Clearance Summary
PAPILLOTOME PRODUCT received FDA 510(k) clearance under submission number K802444, sponsored by Mill-Rose Laboratory. 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 1980-10-23.
- Submission: K802444
- Applicant / Sponsor: Mill-Rose Laboratory
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 1980-10-23
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.