Submission Details
| 510(k) Number | K223476 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 2022 |
| Decision Date | August 07, 2023 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
V-PRO maX 2 Low Temperature Sterilization System
Aug 2023
Decision
262d
Days
Class 2
Risk
About This 510(k) Submission
K223476 is an FDA 510(k) clearance for the V-PRO maX 2 Low Temperature Sterilization System, a Sterilizer, Chemical (Class II — Special Controls, product code MLR), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on August 7, 2023, 262 days after receiving the submission on November 18, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6860.
Device Classification
| Product Code | MLR — Sterilizer, Chemical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6860 |
Manufacturer
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