K233153 is an FDA 510(k) clearance for the Traus SSG10 Surgical System. This device is classified as a Motor, Drill, Electric (Class II - Special Controls, product code HBC).
Submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on September 20, 2024, 359 days after receiving the submission on September 27, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4360.
| 510(k) Number | K233153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2023 |
| Decision Date | September 20, 2024 |
| Days to Decision | 359 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBC - Motor, Drill, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4360 |