STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM— 510(k) K021555

Name: FDA 510(k) clearance K021555
Creator: U.S. Food and Drug Administration
Published: 2003-01-15

Substantially Equivalent

Stereotaxis, Inc.

FDA 510(k) clearance K021555 for STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM, Substantially Equivalent on 2003-01-15. Applicant: Stereotaxis, Inc.. Device class: 2.

Clearance details

Applicant: Stereotaxis, Inc.
Product code: Code DXX
Device class: Class 2
Regulation: 21 CFR 870.1290
Advisory panel: Cardiovascular
Date received: 2002-05-13
Decision date: 2003-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXX

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K262744 — GenesisX RMN2026-08-27
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K243789 — LIBERTY Endovascular Robotic System (LIBERTYOS)2025-09-04
K221464 — CorPath GRX System2022-07-27
K202275 — CorPath GRX System2020-12-11

More clearances from Stereotaxis, Inc.

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K192775 — Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri2019-10-30
K183027 — Steerable catheter control system2019-09-06

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