QZB — Software Controlled Endoscope And Instrument Holder Class II

FDA Device Classification

FDA product code QZB covers "Software Controlled Endoscope And Instrument Holder", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
QZB
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
SU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

To hold and position endoscopes and instruments.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250984moon surgicalMaestro System (REF100)June 27, 2025
K242323moon surgicalMaestro System (REF100)March 14, 2025
K233312aktormedSOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip soloAugust 8, 2024