510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192775Substantially Equivalent

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri

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

K192775 is the FDA 510(k) clearance record for Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri, a class II device, cleared for Stereotaxis, Inc. on under FDA product code PJB (Catheter Remote Control System). FDA's definition for product code PJB reads: "A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation...". FDA records list 28 510(k) clearances for Stereotaxis, Inc., from to . As of , FDA records show one recall naming K192775.

Clearance record

Decision date
Received
(30 days to decision)
Product code
PJB Catheter Remote Control System
Regulation
21 CFR 870.5700
Device class
Class II
Review panel
Cardiovascular
Applicant
Stereotaxis, Inc. 4320 Forest Park Ave., Suite 100, St. Louis MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PJB

Trailing 12 months

FDA records hold no clearances under product code PJB in the trailing twelve months.

FDA records show no clearances under product code PJB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PJB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260