← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

QSM — System, Surgical, Computer Controlled Instrument, Remanufactured

As intended with the originally cleared instrument.

DEVICE CLASS
Class II
REGULATION
21 CFR 876.1500
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES

Recent clearances

K252926Restore Robotics · 510k2026-03-26
K250417Rebotix · 510k2025-08-20
K250399Rebotix · 510k2025-08-19
K250387Rebotix · 510k2025-08-19
K250539Rebotix · 510k2025-08-19
K242610Iconocare Health · 510k2025-03-11
K241872Rebotix · 510k2024-11-07

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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