Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed S
Summary
Vesco Medical, LLC received 510(k) clearance for 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 LZH device. Cleared on 2023-10-23.
Details
Source
510(k) Clearance
External ID
K232205
Action Date
2023-10-23
Status
Traditional
Category
device
Product Code
LZH
Product Description
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. Product code: LZH.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Vesco Medical, LLC have FDA actions?
This is the only FDA action we have on record for Vesco Medical, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232205" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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