510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QSMClass II

System, Surgical, Computer Controlled Instrument, Remanufactured

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QSM is the FDA product code for System, Surgical, Computer Controlled Instrument, Remanufactured, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "As intended with the originally cleared instrument". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QSM
Device name
System, Surgical, Computer Controlled Instrument, Remanufactured
FDA definition
As intended with the originally cleared instrument.
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code QSM

By decision year
8 clearances under product code QSM with a decision year between 2022 and 2026, 2025 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code QSM by decision year
YearClearances
20221
20241
20255
20261

Applicants with the most clearances

Product code QSM
Applicants holding the most 510(k) clearances under product code QSM
ApplicantClearances
Rebotix5
Iconocare Health2
Restore Robotics1

Companies listing this code with FDA

Companies whose registered establishments list this code