K173629 is an FDA 510(k) clearance for the CELERITY 20 Steam Process Challenge Device for Gravity Cycles. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on February 21, 2018, 89 days after receiving the submission on November 24, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K173629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2017 |
| Decision Date | February 21, 2018 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |