K181993 is an FDA 510(k) clearance for the STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R). This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Sturdy Industrial Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on November 1, 2019, 463 days after receiving the submission on July 26, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K181993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2018 |
| Decision Date | November 01, 2019 |
| Days to Decision | 463 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 |