Home / 510(k) Clearances / K203321

510(k) K203321

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 9, 2020
Date Received: November 12, 2020
Clearance Type: Special
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