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510(k) K221410

Maestro Platform by Moon Surgical — Product Code FQO

K221410 is an FDA 510(k) premarket notification submitted by Moon Surgical for the device "Maestro Platform". The FDA issued a decision of Substantially Equivalent on December 2, 2022. The device falls under product code FQO (Table, Operating-Room, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Moon Surgical has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2022
Date Received
May 16, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Ac-Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type

Other clearances by Moon Surgical

  • K250984 — Maestro System (REF100) (June 27, 2025)
  • K242323 — Maestro System (REF100) (March 14, 2025)
  • K240598 — Maestro System (REF100) (June 3, 2024)

Other clearances for product code FQO

  • K240598 — Maestro System (REF100) (June 3, 2024)
  • K090136 — STERIS CMAX XLT SURGICAL TABLE (March 20, 2009)
  • K972810 — OPT80 THE TRANSPORTABLE (OPT80) (August 26, 1997)
  • K971988 — ALLEN, ULTRA AND SMART SOCKETS (July 11, 1997)
  • K971307 — AMSCO SURGICAL TABLE (June 27, 1997)
  • K963506 — TENET RADIOLUCENT HAND TABLE (January 9, 1997)
  • K961886 — DRAGER GEMINA WALL-MOUNTED WORKPLACE (July 30, 1996)
  • K961742 — DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM (July 26, 1996)
  • K955750 — TELETOM (February 8, 1996)
  • K953980 — KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT (November 16, 1995)

FDA data resources