Sterilox Liquid Chemical Sterilant System
FDA 510(k) K063159 · Puricore, Inc.
510(k) numberK063159
Submission
- Device name
- Sterilox Liquid Chemical Sterilant System
- Applicant
- Puricore, Inc.
Radnor, PA, US - Received
- October 17, 2006
- Decision date
- April 2, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MED – Sterilant, Medical Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6885
- Specialty
- General Hospital
Other 510(k)s with product code MED
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid…MED · Traditional | STERIS Corporation | 04/08/2026SE |
| K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid…MED · Special | STERIS Corporation | 10/03/2023SE |
| K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED · Special | STERIS Corporation | 03/28/2023SE |
| K222615 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 09/28/2022SE |
| K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Traditional | STERIS Corporation | 09/07/2021SE |
| K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 05/12/2021SE |
| K192929 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 12/10/2019SE |
| K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900MED · Special | STERIS Corporation | 09/05/2019SE |
| K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical…MED · Special | Steris Corporations | 03/22/2019SE |
| K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900MED · Traditional | STERIS Corporation | 01/31/2019SE |
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| K093155 | Vashe Wound Cleansing SystemFRO · Traditional | 03/01/2010SE |
| K092232 | Modification To:Vashe Wound Cleansing System, Model 9000-0014FRO · Special | 08/19/2009SE |
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Questions and answers
When was Sterilox Liquid Chemical Sterilant System cleared by the FDA?
Sterilox Liquid Chemical Sterilant System (K063159) received a 510(k) decision of Substantially Equivalent on April 2, 2007, 167 days after the submission was received.
What is the product code of K063159?
The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.