K192910 is an FDA 510(k) clearance for the STATClave G4 Chamber Autoclave. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Scican , Ltd. (Toronto, CA). The FDA issued a Cleared decision on June 19, 2020, 248 days after receiving the submission on October 15, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K192910 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2019 |
| Decision Date | June 19, 2020 |
| Days to Decision | 248 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FLE - Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |