K181442 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 June 13, 2018, 12 days after receiving the submission on June 1, 2018.
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 | K181442 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2018 |
| Decision Date | June 13, 2018 |
| Days to Decision | 12 days |
| Submission Type | Special |
| 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. |