XPS 3000 SYSTEM— 510(k) K041523

Substantially Equivalent

Medtronic Xomed, Inc.

FDA 510(k) clearance K041523 for XPS 3000 SYSTEM, Substantially Equivalent on 2004-07-23. Applicant: Medtronic Xomed, Inc..

Clearance details

Applicant: Medtronic Xomed, Inc.
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 2004-06-08
Decision date: 2004-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

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.