Cleared Traditional

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

K232205 · Vesco Medical, LLC · General Hospital
Oct 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K232205 is an FDA 510(k) clearance for the 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, a Pump, Infusion, Enteral (Class II — Special Controls, product code LZH), submitted by Vesco Medical, LLC (Westerville, US). The FDA issued a Cleared decision on October 23, 2023, 90 days after receiving the submission on July 25, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K232205 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2023
Decision Date October 23, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZH — Pump, Infusion, Enteral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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