Medical Device Manufacturer · US , Morrisville , NC

Gilero, LLC

2 submissions · 2 cleared · Since 2021

Total

Cleared

Denied

Gilero, LLC — FDA 510(k) Submissions

Gilero, LLC has submitted 2 FDA 510(k) premarket notifications since 2021, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Container, I.v., Accessories, Pump, Infusion . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

UTC 3mL Medication Cartridge

K230718 · MRZ Accessories, Pump, Infusion · General Hospital

Jun 2023 92d

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL

K201936 · KPE Container, I.v. · General Hospital

May 2021 297d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Gilero, LLC

Gilero, LLC — FDA 510(k) Submissions

Filters