The Eagle 3017 100% Ethylene Oxide Sterilizer
FDA 510(k) K931872 · American Sterilizer Co.
510(k) numberK931872
Submission
- Device name
- The Eagle 3017 100% Ethylene Oxide Sterilizer
- Applicant
- American Sterilizer Co.
Erie, PA, US - Received
- April 14, 1993
- Decision date
- February 7, 1994
- 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
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| 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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| K943288 | Amsco SQ240 Surgical LightFSY · Traditional | 10/17/1994SE |
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| K930493 | Quantum 3080 Surgical TableFQO · Traditional | 06/22/1993SE |
| K905816 | Orthovision TableJEB · Traditional | 03/06/1991SE |
| K896674 | Amsco Quantum LightFSY · Traditional | 01/03/1990SE |
| K895164 | Eagle DSECG · Traditional | 11/17/1989SE |
| K882660 | General Surgical Table and AccessoriesFQO · Traditional | 07/25/1988SE |
| K880198 | Gemini Surgical LightFSS · Traditional | 02/10/1988SE |
| K864846 | Radiographic - Leg SectionKQS · Traditional | 12/24/1986SE |
| K844479 | ChemsporFRC · Traditional | 11/25/1985SN |
Questions and answers
When was The Eagle 3017 100% Ethylene Oxide Sterilizer cleared by the FDA?
The Eagle 3017 100% Ethylene Oxide Sterilizer (K931872) received a 510(k) decision of Substantially Equivalent on February 7, 1994, 299 days after the submission was received.
What is the product code of K931872?
The FDA product code is FLF – Sterilizer, Ethylene-Oxide Gas, a Class II (moderate risk) device regulated under 21 CFR 880.6860.