K233762 is an FDA 510(k) clearance for the SteroScope® Sterilization Technology System. This device is classified as a Sterilizer, Chemical (Class II - Special Controls, product code MLR).
Submitted by Ideate Medical, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 27, 2024, 216 days after receiving the submission on November 24, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K233762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2023 |
| Decision Date | June 27, 2024 |
| Days to Decision | 216 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MLR - Sterilizer, Chemical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6860 |