FLF · Sterilizer, Ethylene-Oxide Gas
General Hospital · 21 CFR 880.6860 · Class 2
Overview
| Product Code | FLF |
|---|---|
| Device Name | Sterilizer, Ethylene-Oxide Gas |
| Regulation | 21 CFR 880.6860 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192978 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | Nov 12, 2020 | SESE |
| K170432 | Anprolene AN75 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | Oct 31, 2017 | SESE |
| K150646 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | Nov 18, 2015 | SESE |
| K142034 | 3M STERI-VAC STERILIZER/AERATOR | 3M Company | Jan 8, 2015 | SESE |
| K090636 | TSO3 OZONE STERILIZER, MODEL 125L | Tso3, Inc. | Dec 2, 2009 | SESE |
| K051595 | TSO3 OZONE STERILIZER, MODEL 125L | Tso3, Inc. | Jul 26, 2006 | SESE |
| K020875 | TSO3 OZONE STERILIZER, MODEL 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | Aug 26, 2003 | SESE |
| K014013 | H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM | H & W Technology, LLC | Jun 25, 2003 | SESE |
| K023290 | STERRAD 50 & STERRAD 100S STERILIZERS | Advanced Sterilization Products | Apr 3, 2003 | SESE |
| K923442 | ABTOX PLAZLYTE PROCESS MONITOR | Abtox, Inc. | Dec 22, 1994 | SESE |
| K905119 | PLAZLYTE(TM) | Abtox, Inc. | Dec 22, 1994 | SESE |
| K941748 | STERI-VAC GAS STERILIZER MODEL 8XL | 3M Health Care, Ltd. | Dec 2, 1994 | SESE |
| K931872 | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER | American Sterilizer Co. | Feb 7, 1994 | SESE |
| K915682 | STERRAD 100 STERILIZATION SYSTEM | Johnson & Johnson Medical, Inc. | Oct 1, 1993 | SESE |
| K920930 | MDT/CASTLE 10/90 DUAL LOAD STATION | Mdt Corp., Inc. | Mar 31, 1993 | SESE |
| K910649 | MDT/CASTLE 10/90 LOAD STATION | Mdt Biologic Co. | Sep 6, 1991 | SESE |
| K901146 | JOSLYN EO STERILIZER/ EO MODERNIZATION KIT | Joslyn Valve Corp. | Mar 7, 1991 | SESE |
| K902036 | STERI-VAC GAS STERILIZER MODEL 5XL | 3M Company | Jul 19, 1990 | SESE |
| K873200 | KARLSON OZONE STERILIZER MODEL 100B | Life Enhancement Technologies, LLC | Jan 27, 1989 | SESE |
| K852115 | ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER | Ars Enterprises, Inc. | Nov 1, 1985 | SESE |
Top Applicants
- 3M Company — 3 clearances
- Andersen Sterilizers, Inc. — 3 clearances
- Abtox, Inc. — 2 clearances
- Tso3, Inc. — 2 clearances
- 3M Health Care, Ltd. — 1 clearance
