Acclarent ENT Navigation System— 510(k) K173628

Substantially Equivalent

Acclarent, Inc.

FDA 510(k) clearance K173628 for Acclarent ENT Navigation System, Substantially Equivalent on 2018-03-10. Applicant: Acclarent, Inc..

Clearance details

Applicant: Acclarent, Inc.
Product code: Code PGW
Advisory panel: Neurology
Date received: 2017-11-24
Decision date: 2018-03-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Menlo Park, 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.