Clearance Summary
ONE-PIECE SHUNT received FDA 510(k) clearance under submission number K834593, sponsored by American Heyer Schulte. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1984-04-03.
- Submission: K834593
- Applicant / Sponsor: American Heyer Schulte
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5550
- Decision date: 1984-04-03
Classification & Regulation
This clearance is catalogued under FDA product code JXG and 21 CFR 882.5550, within the Neurology review panel as a Class II device.