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Applied Urology, Inc.

United StatesFDA applicant, unverified

Devices
13

What Applied Urology, Inc. makes

Applied Urology, Inc. manufactures urological devices including endoscopic valves, ureteral stents, aspiration and irrigation systems, and electrode sheaths for diagnostic and therapeutic procedures. Their portfolio also covers rigid and flexible ureteroscopes, catheters and accessories, percutaneous retractor kits, and retrograde dye injection catheters for imaging. The company produces working channel valves and ureteral access sets for minimally invasive urological interventions.

The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13

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  • Sureseal Endoscopic Valve Ref K920030

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ureteral Stent Ref K920695

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Disposable Aspiration Irrigation System Ref K912093

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Urethral Electrode Sheath Ref K915219

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endoscopic Electrode Ref K912656

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Rigid Ureteroscope Ref K901214

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Urological Catheter And Accessories Ref K925282

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Percutaneous Retractor Kit Ref K912903

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Flexible Endoscopic Electrode Ref K905731

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ureteral Access Set Ref K896385

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ureteropyelogram Cath For Retrograde Dye Injection Ref K903994

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Working Channel Valve Ref K900781

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Acucise Ureteral Cutting Catheter Ref K921838

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-13 of 13

Frequently asked questions

How many devices does Applied Urology, Inc. have in the registry?

The registry currently lists 13 devices for Applied Urology, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Applied Urology, Inc.'s devices?

Among its 13 most recently registered devices, Applied Urology, Inc. has devices listed in FDA 510(k) (13 devices).

What risk classes do Applied Urology, Inc.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Applied Urology, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Applied Urology, Inc. in the registry?

The most recently registered devices listed for Applied Urology, Inc. include SURESEAL ENDOSCOPIC VALVE, URETERAL STENT, DISPOSABLE ASPIRATION IRRIGATION SYSTEM and URETHRAL ELECTRODE SHEATH.

Generated automatically from registry data and not verified by a human reviewer.