XPS NITRO SYSTEM— 510(k) K002828

Substantially Equivalent

Xomed, Inc.

FDA 510(k) clearance K002828 for XPS NITRO SYSTEM, Substantially Equivalent on 2000-10-17. Applicant: Xomed, Inc..

Clearance details

Applicant: Xomed, Inc.
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 2000-09-11
Decision date: 2000-10-17
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.