510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K152670Substantially Equivalent

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables

Medos International SARL, Le Locle, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152670 is the FDA 510(k) clearance record for DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables, a class II device, cleared for Medos International SARL on under FDA product code GWM (Device, Monitoring, Intracranial Pressure). FDA records list 101 510(k) clearances for Medos International SARL, from to . As of , FDA records show no recalls naming K152670.

Clearance record

Decision date
Received
(127 days to decision)
Product code
GWM Device, Monitoring, Intracranial Pressure
Regulation
21 CFR 882.1620
Device class
Class II
Review panel
Neurology
Applicant
Medos International SARL Chemin-Blanc 38, Le Locle, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWM

Trailing 12 months
1 clearance under product code GWM 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 GWM, 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