Submission Details
| 510(k) Number | K243876 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 18, 2024 |
| Decision Date | April 25, 2025 |
| Days to Decision | 128 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
K243876 is an FDA 510(k) clearance for the VERIFY STEAM Integrating Indicator, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on April 25, 2025, 128 days after receiving the submission on December 18, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K243876 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 18, 2024 |
| Decision Date | April 25, 2025 |
| Days to Decision | 128 days |
| Submission Type | Special |
| 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 |