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FDA 510(k)

Cystoject Syringe Lever

K-Number: K203321 · 2020-12-09

ApplicantUrogen Pharma, Ltd.
Decision Date2020-12-09
Product CodeQBL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Cystoject Syringe Lever is a medical device manufactured by Urogen Pharma, Ltd.. It received FDA 510(k) clearance on 2020-12-09 under approval number K203321. The device is classified under product code QBL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cystoject Syringe Lever?

Cystoject Syringe Lever is a medical device that received FDA 510(k) clearance on 2020-12-09. It is manufactured by Urogen Pharma, Ltd.. The 510(k) number is K203321.

When was Cystoject Syringe Lever approved by the FDA?

Cystoject Syringe Lever received FDA 510(k) clearance on 2020-12-09, under approval number K203321.

What company makes Cystoject Syringe Lever?

Cystoject Syringe Lever is manufactured by Urogen Pharma, Ltd..

What is the FDA product code for Cystoject Syringe Lever?

The FDA product code for Cystoject Syringe Lever is QBL.

Other Devices by Urogen Pharma, Ltd.

K180354UroGen Ureteral Catheter K180345Uroject12 Syringe Lever K190987Uroject12 Syringe Lever K211032Urinary Catheter 12 Fr, Urinary Catheter 16 Fr

Related Devices (Code: QBL)

K180345Uroject12 Syringe LeverUrogen Pharma, Ltd. K190987Uroject12 Syringe LeverUrogen Pharma, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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