SAM — Battery-Powered Instruments Charged Through Sterile Barriers Class I
FDA product code SAM covers "Battery-Powered Instruments Charged Through Sterile Barriers", a Class I medical device regulated under 21 CFR 878.4820. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SAM
- Device Class
- Class I
- Regulation Number
- 878.4820
- Submission Type
- Review Panel
- OR
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240071 | peleton surgical | Peleton Universal Single Use Power System and Attachments | April 4, 2024 |