Clearance Summary
HELIX HYDRO-JET received FDA 510(k) clearance under submission number K012464, sponsored by Andreas Pein Medizintechnik GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2001-10-10.
- Submission: K012464
- Applicant / Sponsor: Andreas Pein Medizintechnik GmbH
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5475
- Decision date: 2001-10-10
Classification & Regulation
This clearance is catalogued under FDA product code FQH and 21 CFR 880.5475, within the General Hospital review panel as a Class II device.