SAM
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Battery-Powered Instruments Charged Through Sterile Barriers
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Medical specialty
- General, Plastic Surgery
- FDA definition
- Battery-powered instruments intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissues (bones) and soft tissues. Accessories or attachments may include saw blades, drill chuck, pin driver, and reamer.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Peleton Universal Single Use Power System and Attachments (K240071) | Peleton Surgical | 2024-04-04 |
Track SAM automatically
Every clearance here is in the API, with alerts when new ones post.