FDA Product Code QSM: System, Surgical, Computer Controlled Instrument, Remanufactured
As Intended With The Originally Cleared Instrument.
Leading manufacturers include Rebotix, Iconocare Health and Restore Robotics.
FDA 510(k) Cleared System, Surgical, Computer Controlled Instrument, Remanufactured Devices (Product Code QSM)
About Product Code QSM - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code QSM since 2022, with 8 receiving FDA clearance (average review time: 230 days).
Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QSM have taken an average of 179 days to reach a decision - down from 588 days historically, suggesting improved FDA processing for this classification.
QSM devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →