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QBL — Piston Syringe Lever Class II

FDA Device Classification

Classification Details

Product Code
QBL
Device Class
Class II
Regulation Number
880.5860
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Definition

Controlled compression of a piston syringe

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K203321urogen pharmaCystoject Syringe LeverDecember 9, 2020
K190987urogen pharmaUroject12 Syringe LeverDecember 2, 2019
K180345urogen pharmaUroject12 Syringe LeverOctober 17, 2018