FLF · Class II · 21 CFR 880.6860

FDA Product Code FLF: Sterilizer, Ethylene-oxide Gas

Leading manufacturers include 3M Company, Advanced Sterilization Products and Andersen Sterilizers, Inc..

26
Total
26
Cleared
330d
Avg days
1980
Since

FDA 510(k) Cleared Sterilizer, Ethylene-oxide Gas Devices (Product Code FLF)

26 devices
1–24 of 26
Cleared Nov 12, 2020
EOGas 4 Ethylene Oxide Gas Sterilizer
K192978
Andersen Sterilizers, Inc.
General Hospital · 385d
Cleared Jan 08, 2015
3M STERI-VAC STERILIZER/AERATOR
K142034
3M Company
General Hospital · 164d
Cleared Apr 03, 2003
STERRAD 50 & STERRAD 100S STERILIZERS
K023290
Advanced Sterilization Products
General Hospital · 183d
Cleared Dec 02, 1994
STERI-VAC GAS STERILIZER MODEL 8XL
K941748
3M Health Care, Ltd.
General Hospital · 238d
Cleared Feb 07, 1994
THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER
K931872
American Sterilizer Co.
General Hospital · 299d
Cleared Oct 01, 1993
STERRAD 100 STERILIZATION SYSTEM
K915682
Johnson & Johnson Medical, Inc.
General Hospital · 652d
Cleared Jul 19, 1990
STERI-VAC GAS STERILIZER MODEL 5XL
K902036
3M Company
General Hospital · 77d
Cleared Apr 15, 1982
CASTLE MICROCOMPUTER STERILIZER CONTROL
K820783
Sybron Corp.
General Hospital · 23d
Cleared Nov 02, 1981
STERI-VAC #400C GAS STERILIZER
K812867
3M Company
General Hospital · 20d

About Product Code FLF - Regulatory Context