510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QBLClass II

Piston Syringe Lever

21 CFR 880.5860 / General Hospital
FDA source (opens on fda.gov)

QBL is the FDA product code for Piston Syringe Lever, a class II device type, regulated under 21 CFR 880.5860. FDA's definition for this code reads: "Controlled compression of a piston syringe". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QBL
Device name
Piston Syringe Lever
FDA definition
Controlled compression of a piston syringe
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code QBL

By decision year
3 clearances under product code QBL with a decision year between 2018 and 2020, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QBL by decision year
YearClearances
20181
20191
20201

Applicants with the most clearances

Product code QBL
Applicants holding the most 510(k) clearances under product code QBL
ApplicantClearances
Urogen Pharma Ltd.3

Companies listing this code with FDA

Companies whose registered establishments list this code