Sterilox Liquid Chemical Sterilant System
FDA 510(k) K013280 · Sterilox Technologies, Inc.
510(k) numberK013280
Submission
- Device name
- Sterilox Liquid Chemical Sterilant System
- Applicant
- Sterilox Technologies, Inc.
Yardley, PA, US - Received
- October 2, 2001
- Decision date
- September 18, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
More from STERIS Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K060901 | Vashe Wound Cleansing SystemFRO · Traditional | 06/29/2006SE |
Questions and answers
When was Sterilox Liquid Chemical Sterilant System cleared by the FDA?
Sterilox Liquid Chemical Sterilant System (K013280) received a 510(k) decision of Substantially Equivalent on September 18, 2002, 351 days after the submission was received.
What is the product code of K013280?
The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.