Navient Image Guided Navigation System (ENT) (955-NC-NC)— 510(k) K243053

Substantially Equivalent

Claronav

FDA 510(k) clearance K243053 for Navient Image Guided Navigation System (ENT) (955-NC-NC), Substantially Equivalent on 2025-06-20. Applicant: Claronav.

Clearance details

Applicant: Claronav
Product code: Code PGW
Advisory panel: Neurology
Date received: 2024-09-27
Decision date: 2025-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code PGW

product code PGW

Malfunction: 1,199
Total: 1,199

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.