DeviceClearance

Product code QZB— Gastroenterology, Urology

Maestro System (REF100)

Classification name
Software Controlled Endoscope And Instrument Holder
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
4
First cleared
Most recent

FDA classification definition

“To hold and position endoscopes and instruments.”

— U.S. Food and Drug Administration, device classification record for product code QZB under 21 CFR 876.1500, via openFDA

Market context for product code QZB

FDA has cleared 4 devices under product code QZB between 2024 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QZB

Recent clearances under product code QZB

Data sourced from openFDA. This site is unofficial and independent of the FDA.