Drytouch Suction Stimulator Probe
FDA 510(k) K110712 · Neurovision Medical Products, Inc.
510(k) numberK110712
Submission
- Device name
- Drytouch Suction Stimulator Probe
- Applicant
- Neurovision Medical Products, Inc.
Ventura, CA, US - Received
- March 14, 2011
- Decision date
- June 28, 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
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| K233001 | Bioscope Neuromonitor DeviceETN · Traditional | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | 12/13/2024SE |
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| 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 |
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| K130570 | Neurovision Medical Motion SensorBZQ · Traditional | 12/26/2013SE |
| K130806 | Neurovision Ink Printed Endotracheal Tube ElectrodePDQ · Special | 07/12/2013SE |
| K113771 | Signal Gear Urethral Catheter ElectrodeFAP · Traditional | 12/13/2012SE |
| K121931 | Nondisposable Stimulating InstrumentsETN · Traditional | 10/19/2012SE |
| K110989 | Neurovision Ink Printed Endotracheal Tube ElectrodeETN · Traditional | 11/03/2011SE |
| K110140 | Neurovision Nerve Locator MonitorGWF · Traditional | 09/30/2011SE |
| K110138 | Paired Hydrogel ElectrodeETN · Special | 04/08/2011SE |
| K102862 | Neurovision Se (Nerveana)ETN · Traditional | 12/21/2010SE |
Questions and answers
When was Drytouch Suction Stimulator Probe cleared by the FDA?
Drytouch Suction Stimulator Probe (K110712) received a 510(k) decision of Substantially Equivalent on June 28, 2011, 106 days after the submission was received.
What is the product code of K110712?
The FDA product code is ETN – Stimulator, Nerve, a Class II (moderate risk) device regulated under 21 CFR 874.1820.