HBC
- Product code
- HBC
- Device name
- Motor, Drill, Electric
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4360
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 26
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233153 | 2024-09-20 | Saeshin Precision Co., Ltd. | Traus SSG10 Surgical System | |
| K232938 | 2024-09-16 | Saeshin Precision Co., Ltd. | Traus SSG30 Surgical System |
Official FDA classification page: HBC
Classification and pathway per current FDA publications. Data from openFDA (CC0).