K172319 is an FDA 510(k) clearance for the AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System. 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 January 18, 2018, 170 days after receiving the submission on August 1, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K172319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2017 |
| Decision Date | January 18, 2018 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| 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 |