NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM— 510(k) K013419

Name: FDA 510(k) clearance K013419
Creator: U.S. Food and Drug Administration
Published: 2001-12-20

Substantially Equivalent

Nicolet Biomedical

FDA 510(k) clearance K013419 for NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM, Substantially Equivalent on 2001-12-20. Applicant: Nicolet Biomedical. Device class: 2.

Clearance details

Applicant: Nicolet Biomedical
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2001-10-15
Decision date: 2001-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

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More clearances from Nicolet Biomedical

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K020754 — NICOLET PIONEER TC80802003-04-21
K013281 — VERSALAB APM2002-04-18
K011135 — GSI AUDERA2001-07-26
K010521 — NICOLET VERSALAB2001-03-09
K002766 — NICOLET VASOGUARD2000-11-30

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.