510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162108Substantially Equivalent

Pressio 2 ICP Monitoring System

Sophysa, Orsay, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162108 is the FDA 510(k) clearance record for Pressio 2 ICP Monitoring System, a class II device, cleared for Sophysa SA on under FDA product code GWM (Device, Monitoring, Intracranial Pressure). FDA records list 13 510(k) clearances for Sophysa SA, from to . As of , FDA records show 3 recalls naming K162108.

Clearance record

Decision date
Received
(262 days to decision)
Product code
GWM Device, Monitoring, Intracranial Pressure
Regulation
21 CFR 882.1620
Device class
Class II
Review panel
Neurology
Applicant
Sophysa SA 5 Rue Guy Moquet, Orsay, FR
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