FDA 510(k)

Uroject12 Syringe Lever

K-Number: K190987 · 2019-12-02

Decision Date2019-12-02

Product CodeQBL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Uroject12 Syringe Lever is the device name listed in this FDA 510(k) record. The listed applicant is Urogen Pharma, Ltd.. It received FDA 510(k) clearance on 2019-12-02 under 510(k) number K190987. 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 Uroject12 Syringe Lever?

Uroject12 Syringe Lever is a medical device that received FDA 510(k) clearance on 2019-12-02. The listed applicant is Urogen Pharma, Ltd.. The 510(k) number is K190987.

When did Uroject12 Syringe Lever receive FDA 510(k) clearance?

Uroject12 Syringe Lever received FDA 510(k) clearance on 2019-12-02, under 510(k) number K190987.

Who is the listed applicant for Uroject12 Syringe Lever?

The FDA 510(k) record lists Urogen Pharma, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Uroject12 Syringe Lever?

The FDA product code for Uroject12 Syringe Lever is QBL.

Other records listing Urogen Pharma, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211032Urinary Catheter 12 Fr, Urinary Catheter 16 Fr K203321Cystoject Syringe Lever K180354UroGen Ureteral Catheter K180345Uroject12 Syringe Lever

Related Devices (Code: QBL)

K203321Cystoject Syringe LeverUrogen Pharma, Ltd.K180345Uroject12 Syringe LeverUrogen Pharma, Ltd.

Official Source

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