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Introl Bladder Neck Support Prosthesis With Removal Tool

FDA 510(k)

Class II (US FDA 510(k))

510(k) K965040

by Johnson & Johnson Medical, Inc.

Identifiers

510(k) Number
K965040 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 Introl Bladder Neck Support Prosthesis with Removal Tool is a vaginal pessary designed for the temporary management of genuine stress urinary incontinence. The device consists of a ring-shaped silastic support prosthesis and a rod-shaped removal tool featuring a hook at one end and a handle at the opposite end.

This device is authorized under FDA 510k clearance. It is supplied as a kit containing the prosthesis and the removal tool to facilitate clinical use.

Frequently asked questions

What is the primary purpose of the Introl Bladder Neck Support Prosthesis?

This device is a vaginal pessary intended for the temporary management of genuine stress urinary incontinence. It functions by providing support to the bladder neck.

How is the Introl Bladder Neck Support Prosthesis supplied?

The device is supplied as a kit that includes both the ring-shaped silastic support prosthesis and a rod-shaped removal tool to facilitate clinical use.

What is the function of the included removal tool?

The removal tool is designed to assist in the retrieval of the prosthesis. It features a hook at one end and a handle at the opposite end to allow for controlled removal by a clinician.

What is the regulatory status of this device?

The Introl Bladder Neck Support Prosthesis is authorized under FDA 510k clearance, which indicates it has been found substantially equivalent to legally marketed predicate devices.

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: Introl Bladder Neck Support Prosthesis With Removal Tool, PDF vcd2260 - Food and Drug Administration, fda.innolitics.com, Introl™ bladder neck support prosthesis: International clinical ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Johnson & Johnson Medical, Inc.

Sources (1)

  • FDA 510(k) K965040 24 fields · synced Oct 6, 2026