Product code FLF
- Device name
- Sterilizer, Ethylene-Oxide Gas
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.6860
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192978 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2020-11-12 |
| K170432 | Anprolene AN75 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2017-10-31 |
| K150646 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2015-11-18 |
| K142034 | 3M STERI-VAC STERILIZER/AERATOR | 3M Company | 2015-01-08 |
| K090636 | TSO3 OZONE STERILIZER, MODEL 125L | Tso3, Inc. | 2009-12-02 |
| K051595 | TSO3 OZONE STERILIZER, MODEL 125L | Tso3, Inc. | 2006-07-26 |
| K020875 | TSO3 OZONE STERILIZER, MODEL 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003-08-26 |
| K014013 | H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM | H & W Technology, LLC | 2003-06-25 |
| K023290 | STERRAD 50 & STERRAD 100S STERILIZERS | Advanced Sterilization Products | 2003-04-03 |
| K923442 | ABTOX PLAZLYTE PROCESS MONITOR | Abtox, Inc. | 1994-12-22 |
| K905119 | PLAZLYTE(TM) | Abtox, Inc. | 1994-12-22 |
| K941748 | STERI-VAC GAS STERILIZER MODEL 8XL | 3M Health Care, Ltd. | 1994-12-02 |
| K931872 | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER | American Sterilizer Co. | 1994-02-07 |
| K915682 | STERRAD 100 STERILIZATION SYSTEM | Johnson & Johnson Medical, Inc. | 1993-10-01 |
| K920930 | MDT/CASTLE 10/90 DUAL LOAD STATION | Mdt Corp., Inc. | 1993-03-31 |
| K910649 | MDT/CASTLE 10/90 LOAD STATION | Mdt Biologic Co. | 1991-09-06 |
| K901146 | JOSLYN EO STERILIZER/ EO MODERNIZATION KIT | Joslyn Valve Corp. | 1991-03-07 |
| K902036 | STERI-VAC GAS STERILIZER MODEL 5XL | 3M Company | 1990-07-19 |
| K873200 | KARLSON OZONE STERILIZER MODEL 100B | Life Enhancement Technologies, LLC | 1989-01-27 |
| K852115 | ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER | Ars Enterprises, Inc. | 1985-11-01 |
| K833457 | ETHYLENE OXIDE GAS STERILIZA SYS II | Ben Venue Laboratories, Inc. | 1983-12-29 |
| K832945 | EAGLE 2000 STERILIZER SERIES GAS/AERA | Amsco Co. | 1983-10-19 |
| K821842 | GAS STERILIZATION EQUIPMENT | Getinge International, Inc. | 1982-07-28 |
| K820783 | CASTLE MICROCOMPUTER STERILIZER CONTROL | Sybron Corp. | 1982-04-15 |
| K812867 | STERI-VAC #400C GAS STERILIZER | 3M Company | 1981-11-02 |
| K792660 | 1500 EO EXHAUST HOOD | Castle Co. | 1980-01-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05060485030706 | AN4000.60 EOGas 4 Ethylene Oxide Gas Sterilizer, 115V | ANDERSEN STERILIZERS INC. | 2023-08-31 |
| 05060485030713 | AN4000.61 EOGas 4 Ethylene Oxide Gas Sterilizer, 230V | ANDERSEN STERILIZERS INC. | 2023-08-31 |
| 05060485030744 | AN4000.67 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 230V | ANDERSEN STERILIZERS INC. | 2023-08-31 |
| 10705037067244 | SEALSURE™ | ADVANCED STERILIZATION PRODUCTS SERVICES INC. | 2021-02-11 |
| 00707387787011 | 3M™ Steri-Vac™ | 3M COMPANY | 2020-10-22 |
| 00707387787028 | 3M™ Steri-Vac™ | 3M COMPANY | 2020-10-22 |
| 00707387787561 | 3M™ Steri-Vac™ | 3M COMPANY | 2020-10-22 |
| 00707387787578 | 3M™ Steri-Vac™ | 3M COMPANY | 2020-10-22 |
| 05060485030669 | Anprolene AN75 Refill Kit, 14 Units | ANDERSEN STERILIZERS INC. | 2020-08-14 |
| 05060485030638 | Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V | ANDERSEN STERILIZERS INC. | 2020-08-14 |
| 05060485030621 | Anprolene AN75 Ethylene Oxide Sterilizer, 115V | ANDERSEN STERILIZERS INC. | 2020-08-14 |
| 05060485030614 | Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230V | ANDERSEN STERILIZERS INC. | 2020-08-14 |
| 05060485030607 | Anprolene AN75 Ethylene Oxide Sterilizer | ANDERSEN STERILIZERS INC. | 2020-08-14 |
| 05060485030393 | EOGas 4 Ethylene Oxide Gas Sterilizer | ANDERSEN STERILIZERS INC. | 2018-09-01 |
| 05060485030331 | AN1071 Humidichip | ANDERSEN STERILIZERS INC. | 2018-09-01 |
| 05060485030454 | EOGas 4 Refill Kit | ANDERSEN STERILIZERS INC. | 2018-09-01 |
| 05060485030164 | EOGas 4 Refill Kit | ANDERSEN STERILIZERS INC. | 2018-09-01 |
| 05060485030409 | EOGas 4 Ethylene Oxide Gas Sterilizer | ANDERSEN STERILIZERS INC. | 2018-09-01 |
| 05060485030416 | EOGas 4 Sterilization Bag | ANDERSEN STERILIZERS INC. | 2018-09-01 |
| 05060485030430 | AN1071 Humidichip | ANDERSEN STERILIZERS INC. | 2018-09-01 |
| 05060485030447 | EOGas 4 Refill Kit | ANDERSEN STERILIZERS INC. | 2018-09-01 |
| 50707387767278 | Steri-Vac™ | 3M COMPANY | 2016-09-24 |
| 50707387767261 | Steri-Vac™ | 3M COMPANY | 2016-09-24 |
| 50707387767254 | Steri-Vac™ | 3M COMPANY | 2016-09-24 |
| 50707387767247 | Steri-Vac™ | 3M COMPANY | 2016-09-24 |
| 10705037014460 | Sterrad | ADVANCED STERILIZATION PRODUCTS SERVICES INC. | 2016-09-24 |
| 20705037014658 | Sterrad | ADVANCED STERILIZATION PRODUCTS SERVICES INC. | 2016-09-24 |
| 10705037014651 | Sterrad | ADVANCED STERILIZATION PRODUCTS SERVICES INC. | 2016-09-24 |
| 10705037014583 | STERRAD™ | ADVANCED STERILIZATION PRODUCTS SERVICES INC. | 2016-09-24 |
| 50724995010336 | Envirosystems | STERIS CORPORATION | 2016-09-08 |