SURGICAL STIMULATORS— 510(k) K110422
Substantially EquivalentTechnomed Europe
FDA 510(k) clearance K110422 for SURGICAL STIMULATORS, Substantially Equivalent on 2011-05-26. Applicant: Technomed Europe. Device class: 2.
Clearance details
- Applicant
- Technomed Europe
- 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
- Maastricht-Airport, NL
Recent devices under product code ETN
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- 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 Technomed Europe
view all- K254183 — MR Conditional Cup Electrodes
- K253581 — Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001) +5 more
- K241045 — Disposable Subdermal Needle Electrode, Corkscrew
- K130136 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
- K121257 — LARYNGEAL ELECTRODE
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 K110422
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 K110422.
Data sourced from openFDA. This site is unofficial and independent of the FDA.