Maestro System (REF100)

FDA 510(k) K240598 · Moon Surgical

Substantially Equivalent

510(k) numberK240598

Submission

Device name
Maestro System (REF100)
Applicant
Moon Surgical
Paris, FR
Received
March 4, 2024
Decision date
June 3, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FQO – Table, Operating-Room, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 878.4960
Specialty
General, Plastic Surgery

Other 510(k)s with product code FQO

510(k)DeviceApplicantDecision
K221410Maestro PlatformFQO · Traditional Moon Surgical12/02/2022SE
K090136Steris Cmax XLT Surgical TableFQO · Traditional STERIS Corporation03/20/2009SE
K972810OPT80 the Transportable (OPT80)FQO · Traditional O.P.T. USA, Inc.08/26/1997SE
K971988Allen, Ultra and Smart SocketsFQO · Traditional Allen Medical Systems, Inc.07/11/1997SE
K971307Amsco Surgical TableFQO · Traditional STERIS Corporation06/27/1997SE
K963506Tenet Radiolucent Hand TableFQO · Traditional Tenet Medical Engineering01/09/1997SE
K961886Drager Gemina Wall-Mounted WorkplaceFQO · Traditional Alm Surgical Equipment, Inc.07/30/1996SE
K961742Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series SystemFQO · Traditional Alm Surgical Equipment, Inc.07/26/1996SE
K955750TeletomFQO · Traditional Berchtold Holding GmbH02/08/1996SE
K953980Kreuzer Ceiling Mounted Support Systems, KlinoportFQO · Traditional Kreuzer Corp.11/16/1995SE

More from Kreuzer Corp.

510(k)DeviceDecision
K250984Maestro System (REF100)QZB · Traditional 06/27/2025SE
K242323Maestro System (REF100)QZB · Traditional 03/14/2025SE
K221410Maestro PlatformFQO · Traditional 12/02/2022SE

Questions and answers

When was Maestro System (REF100) cleared by the FDA?

Maestro System (REF100) (K240598) received a 510(k) decision of Substantially Equivalent on June 3, 2024, 91 days after the submission was received.

What is the product code of K240598?

The FDA product code is FQO – Table, Operating-Room, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.