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
FLFClass II

Sterilizer, Ethylene-Oxide Gas

21 CFR 880.6860 / General Hospital
FDA source (opens on fda.gov)

FLF is the FDA product code for Sterilizer, Ethylene-Oxide Gas, a class II device type, regulated under 21 CFR 880.6860. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
FLF
Device name
Sterilizer, Ethylene-Oxide Gas
Regulation
21 CFR 880.6860
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
No
Ingested clearances
26
Ingested recalls
8

Clearances, product code FLF

By decision year
26 clearances under product code FLF with a decision year between 1980 and 2020, 1994 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FLF by decision year
YearClearances
19801
19811
19822
19832
19851
19891
19901
19912
19932
19944
20033
20061
20091
20152
20171
20201

Applicants with the most clearances

Product code FLF
Applicants holding the most 510(k) clearances under product code FLF
ApplicantClearances
Andersen Sterilizers, Inc.3
Abtox, Inc.2
Tso3, Inc.2
3M Company1
3M Company1
3M Company1
3M Company1
Advanced Sterilization Products1
American Sterilizer Co.1
Amsco Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code