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Revive Reusable Bladder Support

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183468

by Rinovum Subsidiary 2, Llc

Identifiers

510(k) Number
K183468 FDA 510(k)
FDA Product Code
HHW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.3575 FDA 510(k)
Regulation Number
884.3575 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Revive Reusable Bladder Support is a vaginal pessary designed to provide mechanical support for pelvic organs, helping to manage stress urinary incontinence by reducing bladder leakage. Classified as a Class II device, it is intended for internal use in the vaginal canal to offer sustained pressure and alignment to the pelvic floor.

This reusable device is supplied sterile upon first use and intended for repeated use with proper cleaning and maintenance. It is not MRI-safe and comes in a single size, requiring no additional accessories. The device holds an FDA 510(k) clearance under the Obstetrics/Gynecology advisory committee and is regulated under the classification code HHW, with registration numbers listed in the FDA database.

Frequently asked questions

How is the Revive Reusable Bladder Support intended to help patients with stress urinary incontinence, and what makes it different from single-use options?

The Revive Reusable Bladder Support is designed to provide mechanical support for pelvic organs by applying sustained pressure within the vaginal canal, which helps reduce bladder leakage associated with stress urinary incontinence. Unlike single-use pessaries, this device is reusable and supplied sterile upon first use, requiring proper cleaning and maintenance for repeated use. Its design focuses on long-term comfort and alignment of the pelvic floor, making it suitable for patients seeking a durable solution.

Is the Revive Reusable Bladder Support safe for use in an MRI environment, and what should clinicians consider before prescribing it?

The Revive Reusable Bladder Support is explicitly not MRI-safe, meaning it should not be used in patients who require MRI scans. Clinicians should assess whether the patient’s treatment plan includes MRI procedures before recommending this device. Since it is reusable and requires proper cleaning, clinicians must also ensure patients understand the maintenance requirements to avoid infection or damage.

What cleaning and maintenance procedures are necessary to ensure the longevity and safety of the Revive Reusable Bladder Support?

Since the Revive Reusable Bladder Support is intended for repeated use, proper cleaning and maintenance are critical to prevent infection and preserve functionality. While the manufacturer’s specific instructions are not detailed here, reusable vaginal pessaries typically require gentle cleaning with mild soap and water after each use, followed by thorough drying. Patients should follow the provided guidelines to avoid damage or contamination, ensuring the device remains effective and safe for ongoing use.

Does the Revive Reusable Bladder Support come in multiple sizes, or is it a one-size-fits-all design?

The Revive Reusable Bladder Support is supplied in a single size, meaning it is not adjustable or available in multiple configurations. Clinicians should confirm patient anatomy and comfort during fitting to ensure proper support and minimize discomfort or displacement. Since it is designed for internal vaginal use, sizing considerations are built into its fixed design.

What regulatory pathway was followed for FDA clearance of the Revive Reusable Bladder Support, and how does this affect its use in clinical practice?

The Revive Reusable Bladder Support received FDA clearance through a 510(k) submission, classified as a Class II device under the Obstetrics/Gynecology advisory committee. The clearance was granted under the Substantially Equivalent (SESE) determination, meaning it was deemed comparable to a legally marketed predicate device. Clinicians can prescribe it with confidence, as it meets FDA standards for safety and effectiveness in managing stress urinary incontinence through mechanical pelvic support.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Rinovum Subsidiary 2, LLC | Pittsburgh, Allegheny, PA, USA Startup, Revive Reusable Bladder Support For Women | Leak Control & Comfort, MAUDE Adverse Event Report: RINOVUM SUBSIDIARY 2, LLC REVIVE REUSABLE ..., Revive Reusable Bladder Support (K183468) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Rinovum Subsidiary 2, Llc

Sources (1)

  • FDA 510(k) K183468 24 fields · synced Sep 19, 2026