Cystoject Syringe Lever— 510(k) K203321

Substantially Equivalent

Urogen Pharma, Ltd.

FDA 510(k) clearance K203321 for Cystoject Syringe Lever, Substantially Equivalent on 2020-12-09. 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: 2020-11-12
Decision date: 2020-12-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Ra'Anana, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QBL

K190987 — Uroject12 Syringe Lever2019-12-02
K180345 — Uroject12 Syringe Lever2018-10-17

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