K220345 is an FDA 510(k) clearance for the STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer. This device is classified as a Sterilizer, Chemical (Class II - Special Controls, product code MLR).
Submitted by Plasmapp Co,., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on April 14, 2023, 431 days after receiving the submission on February 7, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K220345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2022 |
| Decision Date | April 14, 2023 |
| Days to Decision | 431 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 |