K213412 is an FDA 510(k) clearance for the VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Steris Corparation (Mentor, US). The FDA issued a Cleared decision on January 21, 2022, 94 days after receiving the submission on October 19, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K213412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2021 |
| Decision Date | January 21, 2022 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JOJ - Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |