Clearance Summary
PALEX IRRIGATION SET received FDA 510(k) clearance under submission number K904586, sponsored by Palex Intl. SA. 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 1990-12-28.
- Submission: K904586
- Applicant / Sponsor: Palex Intl. SA
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5895
- Decision date: 1990-12-28
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.