FLF — Sterilizer, Ethylene-Oxide Gas Class II
FDA product code FLF covers "Sterilizer, Ethylene-Oxide Gas", a Class II medical device regulated under 21 CFR 880.6860. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K905119 | abtox | PLAZLYTE(TM) | December 22, 1994 |
| K923442 | abtox | ABTOX PLAZLYTE PROCESS MONITOR | 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 |