510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OYCClass III

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Unknown
FDA source (opens on fda.gov)

OYC is the FDA product code for Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor, a class III device type. FDA's definition for this code reads: "The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor". As of , FDA records hold no 510(k) clearances under this code and 34 recalls.

Classification record

Product code
OYC
Device name
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
FDA definition
The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
34

Companies listing this code with FDA

Companies whose registered establishments list this code