K231489 is an FDA 510(k) clearance for the Sturdy Autoclave Super Microm. 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 June 21, 2023, 29 days after receiving the submission on May 23, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K231489 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2023 |
| Decision Date | June 21, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |