K190917 is an FDA 510(k) clearance for the V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems. This device is classified as a Sterilizer, Chemical (Class II - Special Controls, product code MLR).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on May 9, 2019, 30 days after receiving the submission on April 9, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K190917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2019 |
| Decision Date | May 09, 2019 |
| Days to Decision | 30 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 |