510(k) K240071

Peleton Universal Single Use Power System and Attachments by Peleton Surgical — Product Code SAM

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.