510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K943987Substantially Equivalent

Opx-Vx Feberoptic Intracranial Pressure Monitoring Catheter with Drainage

Innerspace Medical, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943987 is the FDA 510(k) clearance record for OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE, a class II device, cleared for Innerspace Medical, Inc. on under FDA product code GWM (Device, Monitoring, Intracranial Pressure). FDA records list one 510(k) clearance for Innerspace Medical, Inc. As of , FDA records show no recalls naming K943987.

Clearance record

Decision date
Received
(113 days to decision)
Product code
GWM Device, Monitoring, Intracranial Pressure
Regulation
21 CFR 882.1620
Device class
Class II
Review panel
Neurology
Applicant
Innerspace Medical, Inc. 1923 SE Main St., Irvine CA
510(k) summary
Summary
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