FLF — Sterilizer, Ethylene-Oxide Gas Class II
FDA Device Classification
Classification Details
- Product Code
- FLF
- Device Class
- Class II
- Regulation Number
- 880.6860
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K192978 | andersen sterilizers | EOGas 4 Ethylene Oxide Gas Sterilizer | November 12, 2020 |
| K170432 | andersen sterilizers | Anprolene AN75 Ethylene Oxide Gas Sterilizer | October 31, 2017 |
| K150646 | andersen sterilizers | EOGas 4 Ethylene Oxide Gas Sterilizer | November 18, 2015 |
| K142034 | 3m | 3M STERI-VAC STERILIZER/AERATOR | January 8, 2015 |
| K090636 | tso3 | TSO3 OZONE STERILIZER, MODEL 125L | December 2, 2009 |
| K051595 | tso3 | TSO3 OZONE STERILIZER, MODEL 125L | July 26, 2006 |
| K020875 | technologies of sterilization with oxone, tso3 | TSO3 OZONE STERILIZER, MODEL 125L | August 26, 2003 |
| K014013 | h and w technology | H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM | June 25, 2003 |
| K023290 | advanced sterilization products | STERRAD 50 & STERRAD 100S STERILIZERS | April 3, 2003 |
| K923442 | abtox | ABTOX PLAZLYTE PROCESS MONITOR | December 22, 1994 |
| K905119 | abtox | PLAZLYTE(TM) | December 22, 1994 |
| K941748 | 3m health care | STERI-VAC GAS STERILIZER MODEL 8XL | December 2, 1994 |
| K931872 | american sterilizer | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER | February 7, 1994 |
| K915682 | johnson and johnson medical | STERRAD 100 STERILIZATION SYSTEM | October 1, 1993 |
| K920930 | mdt corp | MDT/CASTLE 10/90 DUAL LOAD STATION | March 31, 1993 |
| K910649 | mdt biologic | MDT/CASTLE 10/90 LOAD STATION | September 6, 1991 |
| K901146 | joslyn valve | JOSLYN EO STERILIZER/ EO MODERNIZATION KIT | March 7, 1991 |
| K902036 | 3m | STERI-VAC GAS STERILIZER MODEL 5XL | July 19, 1990 |
| K873200 | life enhancement technologies | KARLSON OZONE STERILIZER MODEL 100B | January 27, 1989 |
| K852115 | ars enterprises | ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER | November 1, 1985 |