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.

Clearance details

Applicant: Navi Medical Technologies
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2026-03-20
Decision date: 2026-04-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlton, AU

Download summary PDF View on FDA.gov ↗

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, 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.