K233065 is an FDA 510(k) clearance for the V-PRO maX 2 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 October 20, 2023, 24 days after receiving the submission on September 26, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K233065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2023 |
| Decision Date | October 20, 2023 |
| Days to Decision | 24 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 |