K221227 is an FDA 510(k) clearance for the Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Tuttnauer , Ltd. (Beit-Shemesh, IL). The FDA issued a Cleared decision on September 20, 2022, 145 days after receiving the submission on April 28, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K221227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2022 |
| Decision Date | September 20, 2022 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLE - Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |