Clearance Summary
Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set received FDA 510(k) clearance under submission number K232205, sponsored by Vesco Medical, LLC. 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 2023-10-23.
- Submission: K232205
- Applicant / Sponsor: Vesco Medical, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2023-10-23
Classification & Regulation
This clearance is catalogued under FDA product code LZH and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.