510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN120019Unknown

Cefaly

Stx-Med Sprl, Herstal, Liege, BE / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN120019 is the FDA 510(k) clearance record for CEFALY, a class II device, cleared for Stx-Med Sprl on under FDA product code PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine). FDA's definition for product code PCC reads: "Used to apply an electrical current to a patient's cranium through electrodes placed on the skin". FDA records list one 510(k) clearance for Stx-Med Sprl. As of , FDA records show no recalls naming DEN120019.

Clearance record

Decision date
Received
(453 days to decision)
Product code
PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Regulation
21 CFR 882.5891
Device class
Class II
Review panel
Neurology
Applicant
Stx-Med Sprl Zi Des Haunts Sarts, Herstal, Liege, BE
Third party review
No

Clearances, product code PCC

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