TruDi® Navigation System V3 (FG-2000-00)— 510(k) K231862

Substantially Equivalent

Acclarent, Inc.

FDA 510(k) clearance K231862 for TruDi® Navigation System V3 (FG-2000-00), Substantially Equivalent on 2023-07-21. Applicant: Acclarent, Inc..

Clearance details

Applicant: Acclarent, Inc.
Product code: Code PGW
Advisory panel: Neurology
Date received: 2023-06-23
Decision date: 2023-07-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

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.