Clearance Summary
ON-Q* Pump with Bolus received FDA 510(k) clearance under submission number K181360, sponsored by Halyard Health. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2019-03-22.
- Submission: K181360
- Applicant / Sponsor: Halyard Health
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2019-03-22
Classification & Regulation
This clearance is catalogued under FDA product code MEB and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.