FDA 510(k) Application Details - K240071

Device Classification Name	More FDA Info for this Device
510(K) Number	K240071
Device Name	Peleton Universal Single Use Power System and Attachments
Applicant	Peleton Surgical 1435 North Hayden Road Suite 100 Scottsdale, AZ 85257 US Other 510(k) Applications for this Company
Contact	Andy Bala Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2024
Decision Date	04/04/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review