Steri-Vac #400C Gas Sterilizer
FDA 510(k) K812867 · 3M Company
510(k) numberK812867
Submission
- Device name
- Steri-Vac #400C Gas Sterilizer
- Applicant
- 3M Company
Monrovia, CA, US - Received
- October 13, 1981
- Decision date
- November 2, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FLF – Sterilizer, Ethylene-Oxide Gas
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6860
- Specialty
- General Hospital
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|---|---|---|---|
| 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 |
| K150646 | EOGas 4 Ethylene Oxide Gas SterilizerFLF · Traditional | Andersen Sterilizers, Inc. | 11/18/2015SE |
| 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 |
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| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was Steri-Vac #400C Gas Sterilizer cleared by the FDA?
Steri-Vac #400C Gas Sterilizer (K812867) received a 510(k) decision of Substantially Equivalent on November 2, 1981, 20 days after the submission was received.
What is the product code of K812867?
The FDA product code is FLF – Sterilizer, Ethylene-Oxide Gas, a Class II (moderate risk) device regulated under 21 CFR 880.6860.