Clearance Summary
BLOXOM IRRIGATOR received FDA 510(k) clearance under submission number K871791, sponsored by I.B. Bloxom C/O Hogan & Hartson. 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 1987-05-20.
- Submission: K871791
- Applicant / Sponsor: I.B. Bloxom C/O Hogan & Hartson
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5895
- Decision date: 1987-05-20
Classification & Regulation
This clearance is catalogued under FDA product code EXD and 21 CFR 876.5895, within the Gastroenterology, Urology review panel as a Class II device.