NEXT GEN EMG ENDOTRACHEAL TUBE— 510(k) K112686
Substantially EquivalentMedtronic Xomed, Inc.
FDA 510(k) clearance K112686 for NEXT GEN EMG ENDOTRACHEAL TUBE, Substantially Equivalent on 2012-06-27. 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 K112686
K-number listed on FDA's recall record- Z-0696-2024 — NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK
- Z-0743-2022 — NIM TRIVANTAGE EMG Endotracheal Tube
- Z-1420-2013 — REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112686.
Data sourced from openFDA. This site is unofficial and independent of the FDA.