Uroject12 Syringe Lever— 510(k) K180345

Substantially Equivalent

Urogen Pharma, Ltd.

FDA 510(k) clearance K180345 for Uroject12 Syringe Lever, Substantially Equivalent on 2018-10-17. Applicant: Urogen Pharma, Ltd.. Device class: 2.

Clearance details

Applicant: Urogen Pharma, Ltd.
Product code: Code QBL
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2018-02-08
Decision date: 2018-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: RaAnana, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QBL

K203321 — Cystoject Syringe Lever2020-12-09
K190987 — Uroject12 Syringe Lever2019-12-02

More clearances from Urogen Pharma, Ltd.

K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr2021-11-19
K180354 — UroGen Ureteral Catheter2018-10-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.