XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole— 510(k) K150728
Substantially EquivalentMedtronic Xomed, Inc.
FDA 510(k) clearance K150728 for XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole, Substantially Equivalent on 2015-08-14. Applicant: Medtronic Xomed, Inc..
Clearance details
- Applicant
- Medtronic Xomed, Inc.
- Product code
- Code ERL
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
Adverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
Source: openFDA MAUDE database, through . 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.