K162945 is an FDA 510(k) clearance for the VERIFY ASSERT STEAM Process Challenge Device. This device is classified as a Biological Sterilization Process Indicator With Recombinant-dna Plasmid (Class II - Special Controls, product code OWP).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on April 28, 2017, 189 days after receiving the submission on October 21, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2805. A Recombinant-dna Plasmid Biological Indicator Is Intended For Use By A Health Care Provider To Accompany Products Being Sterilized Through A Sterilization Procedure And To Monitor Adequacy Of Sterilization..
| 510(k) Number | K162945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 2016 |
| Decision Date | April 28, 2017 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | OWP — Biological Sterilization Process Indicator With Recombinant-dna Plasmid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2805 |
| Definition | A Recombinant-dna Plasmid Biological Indicator Is Intended For Use By A Health Care Provider To Accompany Products Being Sterilized Through A Sterilization Procedure And To Monitor Adequacy Of Sterilization. |