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Updated: Oct 12, 2026

Autonomous and Rechargeable Microneurostimulator Endoscopically Implantable into the Submucosa
Published on: September 27, 2018
Medical devices; gastroenterology-urology devices; nonimplanted, peripheral electrical continence device. Food and
Abstract:
The Food and Drug Administration (FDA) is classifying the nonimplanted, peripheral electrical continence device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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