510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253607Substantially Equivalent

UNEEG EpiSight System

Uneeg Medical A/S, Alleroed, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253607 is the FDA 510(k) clearance record for UNEEG EpiSight System, a class II device, cleared for Uneeg Medical A/S on under FDA product code SEM (Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring). FDA's definition for product code SEM reads: "A sub-scalp implanted electroencephalogram (EEG) system for remote patient monitoring is a prescription device used for continuously acquiring, transmitting, and storing electrical brain activity of patients with epilepsy. The device...". FDA records list one 510(k) clearance for Uneeg Medical A/S. As of , FDA records show no recalls naming K253607.

Clearance record

Decision date
Received
(205 days to decision)
Product code
SEM Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
Regulation
21 CFR 882.1360
Device class
Class II
Review panel
Neurology
Applicant
Uneeg Medical A/S Borupvang 2, Alleroed, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SEM

Trailing 12 months
1 clearance under product code SEM in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SEM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260