510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230358Substantially Equivalent

SAVI Dual (TM) Migraine Therapy

eNeura Inc, Baltimore MD / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230358 is the FDA 510(k) clearance record for SAVI Dual (TM) Migraine Therapy, a class II device, cleared for Eneura, Inc. on under FDA product code OKP (Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache). FDA's definition for product code OKP reads: "Transcranial magnetic stimulator for the treatment of migraine headache delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric...". FDA records list 4 510(k) clearances for Eneura, Inc., from to . As of , FDA records show no recalls naming K230358.

Clearance record

Decision date
Received
(95 days to decision)
Product code
OKP Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
Regulation
21 CFR 882.5808
Device class
Class II
Review panel
Neurology
Applicant
Eneura, Inc. 101 W. Dickman St. Suite 900, Baltimore MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OKP

Trailing 12 months

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

FDA records show no clearances under product code OKP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OKP, 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