510(k) K240071

Device

Peleton Universal Single Use Power System and Attachments

Applicant

Peleton Surgical

510(k) number

K240071

Product code

SAM

Decision

Substantially Equivalent (SESE)

Decision date

2024-04-04

Date received

2024-01-10

Regulation

878.4820

Classification name

Battery-Powered Instruments Charged Through Sterile Barriers

Medical specialty

General, Plastic Surgery

Review panel

General, Plastic Surgery

Device class

1

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N