Surgical Stimulators
FDA 510(k) K110422 · Technomed Europe
510(k) numberK110422
Submission
- Device name
- Surgical Stimulators
- Applicant
- Technomed Europe
Maastricht-Airport, NL - Received
- February 14, 2011
- Decision date
- May 26, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ETN – Stimulator, Nerve
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1820
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code ETN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253536 | Evala Nerve Stimulator (EPNR002)ETN · Traditional | Epineuron Technologies, Inc. | 02/27/2026SE |
| K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube…ETN · Traditional | Medtronic Xomed, Inc. | 02/10/2026SE |
| 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…ETN · Traditional | Inomed Medizintechnik GmbH | 06/13/2025SE |
| K233001 | Bioscope Neuromonitor DeviceETN · Traditional | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | 12/13/2024SE |
| K241917 | EARP Nerve Cuff ElectrodeETN · Special | Retropsoas Technologies, LLC | 07/31/2024SE |
| K232888 | Disposable Laryngeal ElectrodesETN · Traditional | Suzhou Haishen Medical Device Associates Co., Ltd. | 12/21/2023SE |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeETN · Special | Medtronic Xomed, Inc. | 10/26/2023SE |
| K230853 | EARP Nerve Cuff ElectrodeETN · Traditional | Nvision Biomedical Technologies, Inc. | 10/06/2023SE |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)ETN · Traditional | Medtronic Xomed, Inc. | 08/30/2023SE |
| K223254 | C2 XploreETN · Traditional | Inomed Medizintechnik GmbH | 01/27/2023SE |
More from Inomed Medizintechnik GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K254183 | MR Conditional Cup ElectrodesGXY · Traditional | 05/07/2026SE |
| K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable…IKT · Traditional | 03/15/2026SE |
| K241045 | Disposable Subdermal Needle Electrode, CorkscrewGXZ · Traditional | 12/11/2024SE |
| K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…GXZ · Traditional | 07/19/2013SE |
| K121257 | Laryngeal ElectrodeETN · Traditional | 08/28/2012SE |
| K073532 | Disposable Adhesive Surface Electrodes, Disc ElectrodesGXY · Traditional | 05/01/2008SE |
| K072016 | Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride…GXY · Traditional | 10/19/2007SE |
| K063729 | Disposable Pedicle Screw Probe, Model 3603-00GXZ · Traditional | 08/21/2007SE |
| K062437 | Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private LabeledIKT · Traditional | 02/16/2007SE |
| K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar ProbeGXZ · Traditional | 05/05/2005SE |
Questions and answers
When was Surgical Stimulators cleared by the FDA?
Surgical Stimulators (K110422) received a 510(k) decision of Substantially Equivalent on May 26, 2011, 101 days after the submission was received.
What is the product code of K110422?
The FDA product code is ETN – Stimulator, Nerve, a Class II (moderate risk) device regulated under 21 CFR 874.1820.