510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FLIClass II

Cabinet, Ethylene-Oxide Gas Aerator

21 CFR 880.6100 / General Hospital
FDA source (opens on fda.gov)

FLI is the FDA product code for Cabinet, Ethylene-Oxide Gas Aerator, a class II device type, regulated under 21 CFR 880.6100. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FLI
Device name
Cabinet, Ethylene-Oxide Gas Aerator
Regulation
21 CFR 880.6100
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
8
Ingested recalls
0

Clearances, product code FLI

By decision year
8 clearances under product code FLI with a decision year between 1977 and 1990, 1983 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FLI by decision year
YearClearances
19771
19781
19791
19811
19832
19902

Applicants with the most clearances

Product code FLI
Applicants holding the most 510(k) clearances under product code FLI
ApplicantClearances
Castle Co.3
3M Company1
Amsco Co.1
Bear Medical Systems, Inc.1
Gas-Vak1
Sybron Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code