K220102 is an FDA 510(k) clearance for the MOST-T Autoclave. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Shinva Medical Instrument Co., Ltd. (Zibo, CN). The FDA issued a Cleared decision on October 12, 2022, 273 days after receiving the submission on January 12, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K220102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2022 |
| Decision Date | October 12, 2022 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FLE - Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |