OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE— 510(k) K943987

Name: FDA 510(k) clearance K943987
Creator: U.S. Food and Drug Administration
Published: 1994-12-07

Substantially Equivalent

Innerspace Medical, Inc.

FDA 510(k) clearance K943987 for OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE, Substantially Equivalent on 1994-12-07. Applicant: Innerspace Medical, Inc.. Device class: 2.

Clearance details

Applicant: Innerspace Medical, Inc.
Product code: Code GWM
Device class: Class 2
Regulation: 21 CFR 882.1620
Advisory panel: Neurology
Date received: 1994-08-16
Decision date: 1994-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.