K222093 is an FDA 510(k) clearance for the V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System. This device is classified as a Sterilizer, Chemical (Class II - Special Controls, product code MLR).
Submitted by Steris (Mentor, US). The FDA issued a Cleared decision on September 9, 2022, 56 days after receiving the submission on July 15, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K222093 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2022 |
| Decision Date | September 09, 2022 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MLR — Sterilizer, Chemical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6860 |