XOMED-TREACE EMG ENDOTRACHEAL TUBEEN— 510(k) K925640
Substantially EquivalentXomed-Treace, Inc.
FDA 510(k) clearance K925640 for XOMED-TREACE EMG ENDOTRACHEAL TUBEEN, Substantially Equivalent on 1993-08-17. Applicant: Xomed-Treace, Inc.. Device class: 2.
Clearance details
- Applicant
- Xomed-Treace, 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 Xomed-Treace, Inc.
view allAdverse 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 K925640
K-number listed on FDA's recall record- Z-1520-2022 — NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
- Z-0901-2017 — NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K925640.
Data sourced from openFDA. This site is unofficial and independent of the FDA.