DeviceClearance

Product code FLF— General Hospital

TSO3 OZONE STERILIZER, MODEL 125L

Classification name
Sterilizer, Ethylene-Oxide Gas
Device class
Class 2
Regulation
21 CFR 880.6860
Advisory panel
General Hospital
Total cleared
26
First cleared
Most recent

Market context for product code FLF

FDA has cleared 26 devices under product code FLF between 1980 and 2020, filed by 20 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 FLF

Recent clearances under product code FLF

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