CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE— 510(k) K050162
Substantially EquivalentMedtronic Xomed, Inc.
FDA 510(k) clearance K050162 for CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE, Substantially Equivalent on 2005-03-03. Applicant: Medtronic Xomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Xomed, Inc.
- Product code
- Code ETN
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
Recent devices under product code ETN
view all- K253536 — Evala Nerve Stimulator (EPNR002)
- K251672 — NIM Essence EMG Endotracheal Tube (5 models)
- K242852 — ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
- K233001 — Bioscope Neuromonitor Device
- K241917 — EARP Nerve Cuff Electrode
More clearances from Medtronic Xomed, Inc.
view all- K262235 — ApexCut Blade with Automated EM Tracking (6 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
- K210841 — NuVent Eustachian Tube Dilation Balloon
Adverse events under product code ETN
product code ETN- Death
- 7
- Injury
- 327
- Malfunction
- 2,776
- Total
- 3,110
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 →
Recalls naming K050162
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050162.
Data sourced from openFDA. This site is unofficial and independent of the FDA.