Submission Details
| 510(k) Number | K192929 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 17, 2019 |
| Decision Date | December 10, 2019 |
| Days to Decision | 54 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
Dec 2019
Decision
54d
Days
Class 2
Risk
About This 510(k) Submission
K192929 is an FDA 510(k) clearance for the SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, a Sterilant, Medical Devices (Class II — Special Controls, product code MED), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on December 10, 2019, 54 days after receiving the submission on October 17, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6885.
Device Classification
| Product Code | MED — Sterilant, Medical Devices |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6885 |
Manufacturer
Similar Devices — MED Sterilant, Medical Devices
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