EOGas 4 Ethylene Oxide Gas Sterilizer
FDA 510(k) K150646 · Andersen Sterilizers, Inc.
510(k) numberK150646
Submission
- Device name
- EOGas 4 Ethylene Oxide Gas Sterilizer
- Applicant
- Andersen Sterilizers, Inc.
Haw River, NC, US - Received
- March 12, 2015
- Decision date
- November 18, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FLF – Sterilizer, Ethylene-Oxide Gas
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6860
- Specialty
- General Hospital
Other 510(k)s with product code FLF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192978 | EOGas 4 Ethylene Oxide Gas SterilizerFLF · Traditional | Andersen Sterilizers, Inc. | 11/12/2020SE |
| K170432 | Anprolene AN75 Ethylene Oxide Gas SterilizerFLF · Traditional | Andersen Sterilizers, Inc. | 10/31/2017SE |
| K142034 | 3M Steri-Vac Sterilizer/AeratorFLF · Abbreviated | 3M Company | 01/08/2015SE |
| K090636 | TSO3 Ozone Sterilizer, Model 125LFLF · Traditional | Tso3, Inc. | 12/02/2009SE |
| K051595 | TSO3 Ozone Sterilizer, Model 125LFLF · Traditional | Tso3, Inc. | 07/26/2006SE |
| K020875 | TSO3 Ozone Sterilizer, Model 125LFLF · Traditional | Technologies of Sterilization With Oxone, Tso3… | 08/26/2003SE |
| K014013 | H & W Hospital Ethylene Oxide Sterilizer Control SystemFLF · Abbreviated | H & W Technology, LLC | 06/25/2003SE |
| K023290 | Sterrad 50 & Sterrad 100S SterilizersFLF · Traditional | Advanced Sterilization Products | 04/03/2003SE |
| K923442 | Abtox Plazlyte Process MonitorFLF · Traditional | Abtox, Inc. | 12/22/1994SE |
| K905119 | Plazlyte(Tm)FLF · Traditional | Abtox, Inc. | 12/22/1994SE |
More from Abtox, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K213296 | Anprolene SteriTest RRBIFRC · Traditional | 04/12/2022SE |
| K202879 | EOGas 4 Endo-SteriTest RRBIFRC · Traditional | 03/03/2021SE |
| K200336 | Tyvek Sterilization Pouches with Chevron SealFRG · Traditional | 11/12/2020SE |
| K200335 | Sterisheet Sterilization WrapFRG · Traditional | 11/12/2020SE |
| K200334 | AN1036 DosimeterJOJ · Traditional | 11/12/2020SE |
| K192980 | EOGas 4 Endo-SteriTestFRC · Traditional | 11/12/2020SE |
| K192978 | EOGas 4 Ethylene Oxide Gas SterilizerFLF · Traditional | 11/12/2020SE |
| K170439 | AN87 DosimeterJOJ · Traditional | 11/01/2017SE |
| K170437 | Sterisheet Sterilization WrapFRG · Traditional | 11/01/2017SE |
| K170432 | Anprolene AN75 Ethylene Oxide Gas SterilizerFLF · Traditional | 10/31/2017SE |
Questions and answers
When was EOGas 4 Ethylene Oxide Gas Sterilizer cleared by the FDA?
EOGas 4 Ethylene Oxide Gas Sterilizer (K150646) received a 510(k) decision of Substantially Equivalent on November 18, 2015, 251 days after the submission was received.
What is the product code of K150646?
The FDA product code is FLF – Sterilizer, Ethylene-Oxide Gas, a Class II (moderate risk) device regulated under 21 CFR 880.6860.