Product code QSM

Device name

System, Surgical, Computer Controlled Instrument, Remanufactured

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.1500

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

As intended with the originally cleared instrument.

Source

FDA openFDA device classification dataset