Submission Details
| 510(k) Number | K191343 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 20, 2019 |
| Decision Date | September 05, 2019 |
| Days to Decision | 108 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
Sep 2019
Decision
108d
Days
Class 2
Risk
About This 510(k) Submission
K191343 is an FDA 510(k) clearance for the 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 September 5, 2019, 108 days after receiving the submission on May 20, 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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