DeviceClearance

Product code QBL— General Hospital

Uroject12 Syringe Lever

Classification name
Piston Syringe Lever
Device class
Class 2
Regulation
21 CFR 880.5860
Advisory panel
General Hospital
Total cleared
3
First cleared
Most recent

FDA classification definition

“Controlled compression of a piston syringe”

— U.S. Food and Drug Administration, device classification record for product code QBL under 21 CFR 880.5860, via openFDA

Market context for product code QBL

FDA has cleared 3 devices under product code QBL between 2018 and 2020, filed by 1 applicant company. 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 QBL

Recent clearances under product code QBL

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