510(k) K172319 ยท MLR Sterilizer, Chemical
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
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Jan 18, 2018 |
| Received | Aug 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172319
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2018 | Steris Corporation AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems
The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intend Terminated |
MLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.