Maestro System (REF100)

510(k) Number

K240598 ↗

FDA product code

FQO

FDA applicant

Moon Surgical

Device class

Class I

Regulation

21 CFR Part 878.4960

Advisory committee

General, Plastic Surgery

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code FQO (Table, Operating-Room, Ac-Powered).

• Transfer table top 118013A0 by Maquet, Inc.
• OPT80 THE TRANSPORTABLE (OPT80) by O.P.T. USA, Inc.
• Stationary transformer unit 115080A0 by Maquet, Inc.
• Column/Head GG16013 by Drägerwerk AG & Co. KGaA
• TENET RADIOLUCENT HAND TABLE by Tenet Medical Engineering
• 0682400605 0682-400-605 by STRYKER Communications, Inc.
• 712 PLASTIC SURGERY TABLE & ACCESORIES by Midmark Corporation
• BF853 by STERIS CORPORATION
• BF215 by STERIS CORPORATION
• IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE by Mdt Corp., Inc.

• Maestro System

  Class I

  CE/MDR

• Maestro System 100

  Class II

  FDA 510(k) ×3 Active Cleared 3 Jun 2024 GUDID on market

• Maestro Couplers, 5mm 200

  Class I

  FDA 510(k) K240598 Active Cleared 3 Jun 2024 GUDID on market

• Maestro Couplers, 10mm 201

  Class I

  CE/MDR FDA 510(k) K240598 Active Cleared 3 Jun 2024 +1authorizations

See all devices from Moon Surgical, Inc. →