K240071 is an FDA 510(k) clearance for the Peleton Universal Single Use Power System and Attachments. This device is classified as a Battery-powered Instruments Charged Through Sterile Barriers (Class I - General Controls, product code SAM).
Submitted by Peleton Surgical (Scottsdale, US). The FDA issued a Cleared decision on April 4, 2024, 85 days after receiving the submission on January 10, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820. 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..
| 510(k) Number | K240071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2024 |
| Decision Date | April 04, 2024 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | SAM - Battery-powered Instruments Charged Through Sterile Barriers |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |
| 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. |