K210326 is an FDA 510(k) clearance for the Bravo 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 July 1, 2021, 147 days after receiving the submission on February 4, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K210326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2021 |
| Decision Date | July 01, 2021 |
| Days to Decision | 147 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 |