TruDi Probe— 510(k) K193453

Substantially Equivalent

Acclarent, Inc.

FDA 510(k) clearance K193453 for TruDi Probe, Substantially Equivalent on 2020-03-23. Applicant: Acclarent, Inc..

Clearance details

Applicant: Acclarent, Inc.
Product code: Code PGW
Advisory panel: Neurology
Date received: 2019-12-13
Decision date: 2020-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
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.