510(k) K252024

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

October 16, 2025

Date Received

June 30, 2025

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

Device Class

Class II

Regulation Number

876.5340

Review Panel

GU

Submission Type

A non-implanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain.