FQO · Class I · 21 CFR 878.4960

FDA Product Code FQO: Table, Operating-room, Ac-powered

Leading manufacturers include STERIS Corporation and Moon Surgical.

35
Total
35
Cleared
106d
Avg days
1983
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Table, Operating-room, Ac-powered Devices (Product Code FQO)

35 devices
1–24 of 35
Cleared Jun 03, 2024
Maestro System (REF100)
K240598
Moon Surgical
General & Plastic Surgery · 91d
Cleared Dec 02, 2022
Maestro Platform
K221410
Moon Surgical
General & Plastic Surgery · 200d
Cleared Mar 20, 2009
STERIS CMAX XLT SURGICAL TABLE
K090136
STERIS Corporation
General & Plastic Surgery · 58d
Cleared Jun 27, 1997
AMSCO SURGICAL TABLE
K971307
STERIS Corporation
General & Plastic Surgery · 80d

About Product Code FQO - Regulatory Context

510(k) Submission Activity

35 total 510(k) submissions under product code FQO since 1983, with 35 receiving FDA clearance (average review time: 106 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.