K242795 is an FDA 510(k) clearance for the Getinge Assured MI Steam Migrating Integrator. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Steritec Products Mfg. (A Getinge Group Company) (Engelwood, US). The FDA issued a Cleared decision on October 15, 2024, 29 days after receiving the submission on September 16, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K242795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2024 |
| Decision Date | October 15, 2024 |
| Days to Decision | 29 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 |