DeviceClearance

Neonav ECG Tip Location System— 510(k) K260929

Substantially Equivalent

Navi Medical Technologies

FDA 510(k) clearance K260929 for Neonav ECG Tip Location System, Substantially Equivalent on 2026-04-17. Applicant: Navi Medical Technologies. Device class: 2.

Summary

Navi Medical Technologies' Neonav ECG Tip Location System is filed under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 880.5970. The record lists General Hospital as the classification panel, but the Cardiovascular review panel handled this Special 510(k).

Navi Medical Technologies filed from Carlton, Australia. Review took 28 calendar days (March 20 to April 17, 2026).

Clearance details

Applicant
Navi Medical Technologies
Product code
Product code LJS
Device class
Class 2
Regulation
21 CFR 880.5970
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Carlton, AU
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LJS

product code LJS
Death
31
Injury
2,791
Malfunction
18,374
Other
5
Total
21,201

Source: openFDA MAUDE database, through . 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.