EOGas 4 Ethylene Oxide Gas Sterilizer
FDA 510(k) clearance K150646 · decided 2015-11-18
Clearance details
- K-number
- K150646
- Device name
- EOGas 4 Ethylene Oxide Gas Sterilizer
- Applicant
- Andersen Sterilizers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-12
- Decision date
- 2015-11-18
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- FLF
- Device class
- 2
- Regulation number
- 880.6860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Haw River, NC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EOGas 4 Ethylene Oxide Gas Sterilizer (K192978) | Andersen Sterilizers, Inc. | 2020-11-12 |
| Anprolene AN75 Ethylene Oxide Gas Sterilizer (K170432) | Andersen Sterilizers, Inc. | 2017-10-31 |
| 3M STERI-VAC STERILIZER/AERATOR (K142034) | 3M Company | 2015-01-08 |
| TSO3 OZONE STERILIZER, MODEL 125L (K090636) | Tso3, Inc. | 2009-12-02 |
| TSO3 OZONE STERILIZER, MODEL 125L (K051595) | Tso3, Inc. | 2006-07-26 |
| TSO3 OZONE STERILIZER, MODEL 125L (K020875) | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003-08-26 |
| H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (K014013) | H & W Technology, LLC | 2003-06-25 |
| STERRAD 50 & STERRAD 100S STERILIZERS (K023290) | Advanced Sterilization Products | 2003-04-03 |
| ABTOX PLAZLYTE PROCESS MONITOR (K923442) | Abtox, Inc. | 1994-12-22 |
| PLAZLYTE(TM) (K905119) | Abtox, Inc. | 1994-12-22 |
| STERI-VAC GAS STERILIZER MODEL 8XL (K941748) | 3M Health Care, Ltd. | 1994-12-02 |
| THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER (K931872) | American Sterilizer Co. | 1994-02-07 |
Recalls involving this device
No recalls on record reference this clearance.