Product code QSM— Gastroenterology, Urology

8mm Monopolar Curved Scissors

Classification name
System, Surgical, Computer Controlled Instrument, Remanufactured
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
8
First cleared
Most recent

FDA classification definition

“As intended with the originally cleared instrument.”

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

Market context for product code QSM

FDA has cleared 8 devices under product code QSM between 2022 and 2026, filed by 3 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 QSM

Recent clearances under product code QSM

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