K222608 is an FDA 510(k) clearance for the Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS. 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 December 16, 2022, 109 days after receiving the submission on August 29, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K222608 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2022 |
| Decision Date | December 16, 2022 |
| Days to Decision | 109 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 |