Evadri Bladder Control Systems

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K050483 ↗

FDA Product Code

KPI

Device Class

Class II

Regulation

21 CFR Part 876.5320

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Hollister, Inc. →

• What types of urinary incontinence can the Evadri Bladder Control Systems help manage, and how does it work?

  The Evadri Bladder Control Systems are designed specifically for managing neurogenic or stress incontinence by delivering electrical stimulation or EMG biofeedback. These devices work by strengthening pelvic floor muscles through targeted electrical impulses, helping patients regain better bladder control. They are intended for use in clinical settings like urology and gastroenterology practices, where trained professionals apply them to patients.

• Are the Evadri Bladder Control Systems reusable or single-use, and how should they be stored?

  The Evadri Bladder Control Systems are reusable medical devices, meaning they are designed for repeated use in clinical settings. Proper storage and handling follow standard medical device protocols to maintain functionality and ensure sterility. Since they are not single-use, they must be cleaned, disinfected, and stored according to manufacturer guidelines to prevent contamination and preserve performance.

• What regulatory pathway was followed for FDA clearance of the Evadri Bladder Control Systems, and what classification does it hold?

  The Evadri Bladder Control Systems received FDA 510(k) clearance under regulation number 876.5320, which classifies them as Class II devices. The clearance was granted through a traditional 510(k) review pathway, with a decision of Substantially Equivalent (SESE). This means the device was determined to be as safe and effective as a legally marketed predicate device.

• In which medical specialties are the Evadri Bladder Control Systems primarily used, and where can they be applied?

  The Evadri Bladder Control Systems are primarily intended for use in urology and gastroenterology practices, as indicated by their advisory committee classification. They are designed for application in clinical settings where trained professionals can administer electrical stimulation or EMG biofeedback to patients with urinary incontinence, helping manage neurogenic or stress-related bladder control issues.