Opaciden Solution
FDA 510(k) K070627 · Ciden Technologies, LLC
510(k) numberK070627
Submission
- Device name
- Opaciden Solution
- Applicant
- Ciden Technologies, LLC
Bellaire, TX, US - Received
- March 6, 2007
- Decision date
- August 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
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| 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 |
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| 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 |
|---|---|---|
| K140703 | Opa 30 SolutionMED · Traditional | 08/19/2014SE |
Questions and answers
When was Opaciden Solution cleared by the FDA?
Opaciden Solution (K070627) received a 510(k) decision of Substantially Equivalent on August 2, 2007, 149 days after the submission was received.
What is the product code of K070627?
The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.