Submission Details
| 510(k) Number | K232914 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 19, 2023 |
| Decision Date | October 03, 2023 |
| Days to Decision | 14 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)
Oct 2023
Decision
14d
Days
Class 2
Risk
About This 510(k) Submission
K232914 is an FDA 510(k) clearance for the SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (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 October 3, 2023, 14 days after receiving the submission on September 19, 2023. 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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