LARYNGEAL SURFACE ELECTRODE— 510(k) K093373
Substantially EquivalentSpes Medica Srl
FDA 510(k) clearance K093373 for LARYNGEAL SURFACE ELECTRODE, Substantially Equivalent on 2010-08-24. Applicant: Spes Medica Srl. Device class: 2.
Clearance details
- Applicant
- Spes Medica Srl
- 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
- Battipaglia, IT
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- K233001 — Bioscope Neuromonitor Device
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More clearances from Spes Medica Srl
view all- K211954 — Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
- K212326 — AC Cream - Conductive paste
- K192606 — SAC2 - Electrode Cream
- K192603 — Spes Medica Subdermal Needle Electrodes
- K190050 — Tech Dots - Adhesive and conductive gel
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 K093373
K-number listed on FDA's recall record- Z-1967-2021 — Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.
- Z-1969-2021 — Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093373.
Data sourced from openFDA. This site is unofficial and independent of the FDA.