510(k) K240071
K240071 is an FDA 510(k) premarket notification submitted by Peleton Surgical for the device "Peleton Universal Single Use Power System and Attachments". The FDA issued a decision of Substantially Equivalent on April 4, 2024. The device falls under product code SAM (Battery-Powered Instruments Charged Through Sterile Barriers), a Class I device regulated under 21 CFR 878.4820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2024
- Date Received
- January 10, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Battery-Powered Instruments Charged Through Sterile Barriers
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- OR
- Submission Type
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.