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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Battery-Powered Instruments Charged Through Sterile Barriers
510(k) Number K240071
Device Name Peleton Universal Single Use Power System and Attachments
Applicant
Peleton Surgical
1435 N. Hayden Rd.
Suite 100
Scottsdale,  AZ  85257
Applicant Contact Andy Bala
Correspondent
Peleton Surgical
1435 N. Hayden Rd.
Suite 100
Scottsdale,  AZ  85257
Correspondent Contact Andy Bala
Regulation Number878.4820
Classification Product Code
SAM  
Date Received01/10/2024
Decision Date 04/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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