510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180345Substantially Equivalent

Uroject12 Syringe Lever

Urogen Pharma Ltd., Ra’Anana, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180345 is the FDA 510(k) clearance record for Uroject12 Syringe Lever, a class II device, cleared for Urogen Pharma, Ltd. on under FDA product code QBL (Piston Syringe Lever). FDA's definition for product code QBL reads: "Controlled compression of a piston syringe". FDA records list 5 510(k) clearances for Urogen Pharma, Ltd., from to . As of , FDA records show no recalls naming K180345.

Clearance record

Decision date
Received
(251 days to decision)
Product code
QBL Piston Syringe Lever
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Urogen Pharma, Ltd. 9 Ha`Ta`Asiya St., Ra’Anana, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QBL

Trailing 12 months

FDA records hold no clearances under product code QBL in the trailing twelve months.

FDA records show no clearances under product code QBL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QBL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260