K162701 is an FDA 510(k) clearance for the VERIFY Assert Self-Contained Biological Indicator. 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 March 24, 2017, 177 days after receiving the submission on September 28, 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 | K162701 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2016 |
| Decision Date | March 24, 2017 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| 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. |