Modification to Sporicidin Sterilizing and Disinfecting Solution
FDA 510(k) K003087 · Sporicidin Intl.
510(k) numberK003087
Submission
- Device name
- Modification to Sporicidin Sterilizing and Disinfecting Solution
- Applicant
- Sporicidin Intl.
Rockville, MD, US - Received
- September 27, 2000
- Decision date
- November 7, 2000
- 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 |
| 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 |
|---|---|---|
| K983194 | Sporicidin Sterilizing and Disinfecting Solution (SSDS)MED · Traditional | 03/05/1999SE |
| K926013 | Sporicidin Brand Disinfect Towel, Spray/Solut ModiLRJ · Traditional | 02/12/1993SE |
| K922262 | Sporicidin Brand Disinfect Towelettes/Spray/SolutLRJ · Traditional | 09/15/1992SN |
| K904581 | Sporicidin Brand Disinfectant SolutionLRJ · Traditional | 05/18/1992SE |
| K904580 | Sporicidin Brand Disinfectant SprayLRJ · Traditional | 05/18/1992SE |
| K904579 | Sporicidin Brand Disinfectant TowelettesLRJ · Traditional | 05/18/1992SE |
| K830722 | Sporididin-D Cold Sterilizing/SolutionLIF · Traditional | 06/30/1983SE |
Questions and answers
When was Modification to Sporicidin Sterilizing and Disinfecting Solution cleared by the FDA?
Modification to Sporicidin Sterilizing and Disinfecting Solution (K003087) received a 510(k) decision of Substantially Equivalent on November 7, 2000, 41 days after the submission was received.
What is the product code of K003087?
The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.