510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252024Substantially Equivalent

NeurAxis IB-Stim (01-1020)

Neuraxis, Inc, Carmel IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252024 is the FDA 510(k) clearance record for NeurAxis IB-Stim (01-1020), a class II device, cleared for Neuraxis on under FDA product code QHH (Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)). FDA's definition for product code QHH reads: "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...". FDA records list 4 510(k) clearances for Neuraxis, from to . As of , FDA records show no recalls naming K252024.

Clearance record

Decision date
Received
(108 days to decision)
Product code
QHH Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
Regulation
21 CFR 876.5340
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Neuraxis 11611 N. Meridian St., Carmel IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QHH

Trailing 12 months

FDA records hold no clearances under product code QHH in the trailing twelve months.

FDA records show no clearances under product code QHH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QHH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260