NEUROSCOPE SEEG— 510(k) K861884

Substantially Equivalent

Siegen Corp.

FDA 510(k) clearance K861884 for NEUROSCOPE SEEG, Substantially Equivalent on 1986-10-14. Applicant: Siegen Corp..

Clearance details

Applicant: Siegen Corp.
Product code: Code GWO
Advisory panel: Neurology
Date received: 1986-05-15
Decision date: 1986-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.