Home / 510(k) Clearances / K180345

510(k) K180345

Uroject12 Syringe Lever by Urogen Pharma, Ltd. — Product Code QBL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 17, 2018
Date Received: February 8, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Piston Syringe Lever
Device Class: Class II
Regulation Number: 880.5860
Review Panel: HO
Submission Type

Controlled compression of a piston syringe