Peleton Universal Single Use Power System and Attachments— 510(k) K240071

Name: FDA 510(k) clearance K240071
Creator: U.S. Food and Drug Administration
Published: 2024-04-04

Substantially Equivalent

Peleton Surgical

FDA 510(k) clearance K240071 for Peleton Universal Single Use Power System and Attachments, Substantially Equivalent on 2024-04-04. Applicant: Peleton Surgical. Device class: 1.

Clearance details

Applicant: Peleton Surgical
Product code: Code SAM
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 2024-01-10
Decision date: 2024-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

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