Clearance Summary
MONOCRYSTANT PH/LES CATHETER, MODIFICATION received FDA 510(k) clearance under submission number K914793, sponsored by Synectics-Dantec. 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 1993-12-13.
- Submission: K914793
- Applicant / Sponsor: Synectics-Dantec
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 1993-12-13
Classification & Regulation
This clearance is catalogued under FDA product code KLA and 21 CFR 876.1725, within the Gastroenterology, Urology review panel as a Class II device.