EM SINUS DILATION SYSTEM— 510(k) K132297
Substantially EquivalentMedtronic Xomed, Inc.
FDA 510(k) clearance K132297 for EM SINUS DILATION SYSTEM, Substantially Equivalent on 2013-11-05. Applicant: Medtronic Xomed, Inc.. Device class: 1.
Clearance details
- Applicant
- Medtronic Xomed, Inc.
- Product code
- Code LRC
- Device class
- Class 1
- Regulation
- 21 CFR 874.4420
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
Recent devices under product code LRC
view allMore clearances from Medtronic Xomed, Inc.
view all- K262235 — ApexCut Blade with Automated EM Tracking (6 models)
- K251672 — NIM Essence EMG Endotracheal Tube (5 models)
- K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
- K231580 — NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
- K213246 — NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
Adverse events under product code LRC
product code LRC- Death
- 5
- Total
- 5
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.