Product code SAM— General, Plastic Surgery
Peleton Universal Single Use Power System and Attachments
- Classification name
- Battery-Powered Instruments Charged Through Sterile Barriers
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code SAM
FDA has cleared device under product code SAM, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code SAM
Recent clearances under product code SAM
Data sourced from openFDA. This site is unofficial and independent of the FDA.