DeviceClearance

Product code LZG— General Hospital

AMIGO INSULIN PUMP

Classification name
Pump, Infusion, Insulin
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Total cleared
84
First cleared
Most recent

Market context for product code LZG

FDA has cleared 84 devices under product code LZG between 1989 and 2026, filed by 29 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LZG

Adverse events under product code LZG

product code LZG
Death
104
Injury
12,022
Malfunction
135,004
Other
1
Total
147,131

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LZG

Data sourced from openFDA. This site is unofficial and independent of the FDA.