Uroject12 Syringe Lever

FDA 510(k) K190987 · Urogen Pharma, Ltd.

Substantially Equivalent

510(k) numberK190987

Submission

Device name
Uroject12 Syringe Lever
Applicant
Urogen Pharma, Ltd.
Ra’Anana, IL
Received
April 15, 2019
Decision date
December 2, 2019
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QBL – Piston Syringe Lever
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5860
Specialty
General Hospital

Controlled compression of a piston syringe

Other 510(k)s with product code QBL

510(k)DeviceApplicantDecision
K203321Cystoject Syringe LeverQBL · Special Urogen Pharma, Ltd.12/09/2020SE
K180345Uroject12 Syringe LeverQBL · Traditional Urogen Pharma, Ltd.10/17/2018SE

More from Urogen Pharma, Ltd.

510(k)DeviceDecision
K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrKOD · Traditional 11/19/2021SE
K203321Cystoject Syringe LeverQBL · Special 12/09/2020SE
K180354UroGen Ureteral CatheterKOD · Traditional 10/30/2018SE
K180345Uroject12 Syringe LeverQBL · Traditional 10/17/2018SE

Questions and answers

When was Uroject12 Syringe Lever cleared by the FDA?

Uroject12 Syringe Lever (K190987) received a 510(k) decision of Substantially Equivalent on December 2, 2019, 231 days after the submission was received.

What is the product code of K190987?

The FDA product code is QBL – Piston Syringe Lever, a Class II (moderate risk) device regulated under 21 CFR 880.5860.