FLF · Class II · 21 CFR 880.6860

FDA Product Code FLF: Sterilizer, Ethylene-oxide Gas

Leading manufacturers include 3M Company, Andersen Sterilizers, Inc. and Tso3, 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 Oct 31, 2017
Anprolene AN75 Ethylene Oxide Gas Sterilizer
K170432
Andersen Sterilizers, Inc.
General Hospital · 260d
Cleared Nov 18, 2015
EOGas 4 Ethylene Oxide Gas Sterilizer
K150646
Andersen Sterilizers, Inc.
General Hospital · 251d
Cleared Jan 08, 2015
3M STERI-VAC STERILIZER/AERATOR
K142034
3M Company
General Hospital · 164d
Cleared Dec 02, 2009
TSO3 OZONE STERILIZER, MODEL 125L
K090636
Tso3, Inc.
General Hospital · 267d
Cleared Jul 26, 2006
TSO3 OZONE STERILIZER, MODEL 125L
K051595
Tso3, Inc.
General Hospital · 405d
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 Mar 31, 1993
MDT/CASTLE 10/90 DUAL LOAD STATION
K920930
Mdt Corp., Inc.
General Hospital · 397d
Cleared Jul 19, 1990
STERI-VAC GAS STERILIZER MODEL 5XL
K902036
3M Company
General Hospital · 77d
Cleared Oct 19, 1983
EAGLE 2000 STERILIZER SERIES GAS/AERA
K832945
Amsco Co.
General Hospital · 50d
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
Cleared Jan 29, 1980
1500 EO EXHAUST HOOD
K792660
Castle Co.
General Hospital · 33d

About Product Code FLF - Regulatory Context