Cleared Traditional

Maestro System (REF100)

K240598 · Moon Surgical · General & Plastic Surgery

Jun 2024

Decision

91d

Days

Class 1

Risk

About This 510(k) Submission

K240598 is an FDA 510(k) clearance for the Maestro System (REF100), a Table, Operating-room, Ac-powered (Class I — General Controls, product code FQO), submitted by Moon Surgical (Paris, FR). The FDA issued a Cleared decision on June 3, 2024, 91 days after receiving the submission on March 4, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number	K240598 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2024
Decision Date	June 03, 2024
Days to Decision	91 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF