510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051760Substantially Equivalent

Navigant Workstation with Niobe Magnetic Navigation System, Model Nws05

Stereotaxis Inc, Saint Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051760 is the FDA 510(k) clearance record for NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05, a class II device, cleared for Stereotaxis, Inc. on under FDA product code DXX (System, Catheter Control, Steerable). FDA records list 28 510(k) clearances for Stereotaxis, Inc., from to . As of , FDA records show no recalls naming K051760.

Clearance record

Decision date
Received
(310 days to decision)
Product code
DXX System, Catheter Control, Steerable
Regulation
21 CFR 870.1290
Device class
Class II
Review panel
Cardiovascular
Applicant
Stereotaxis, Inc. 4041 Forest Park Ave., Saint Louis MO
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DXX

Trailing 12 months
2 clearances under product code DXX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260