510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221123Substantially Equivalent

WISE Cortical Strip (WCS)

Wise S.r.l., Cologno Monzese, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221123 is the FDA 510(k) clearance record for WISE Cortical Strip (WCS), a class II device, cleared for Wise S.R.L. on under FDA product code GYC (Electrode, Cortical). FDA records list one 510(k) clearance for Wise S.R.L. As of , FDA records show no recalls naming K221123.

Clearance record

Decision date
Received
(218 days to decision)
Product code
GYC Electrode, Cortical
Regulation
21 CFR 882.1310
Device class
Class II
Review panel
Neurology
Applicant
Wise S.R.L. Via Michelangelo Buonarroti ,38, Cologno Monzese, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GYC

Trailing 12 months

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

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