DeviceClearance

Product code FLE— General Hospital

AMSCO 600 Steam Sterilizer

Classification name
Sterilizer, Steam
Device class
Class 2
Regulation
21 CFR 880.6880
Advisory panel
General Hospital
Total cleared
185
First cleared
Most recent

Market context for product code FLE

FDA has cleared 185 devices under product code FLE between 1977 and 2026, filed by 84 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 FLE

Adverse events under product code FLE

product code FLE
Malfunction
444
Total
444

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 FLE

1–100 of 185

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