Porex Nerve Locator
FDA 510(k) K872791 · Porex Medical
510(k) numberK872791
Submission
- Device name
- Porex Nerve Locator
- Applicant
- Porex Medical
Fairburn, GA, US - Received
- July 14, 1987
- Decision date
- October 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K873044 | Porex Otology InstrumentsLRC · Traditional | 09/04/1987SE |
| K872947 | Porex Quality Plastic Surgery InstrumentsKDG · Traditional | 08/21/1987SE |
| K863946 | Porex(Tm) Extra-Ocular Orbital ImplantHQX · Traditional | 02/27/1987SE |
| K863943 | Porex(Tm) Eye Sphere ImplantHPZ · Traditional | 02/27/1987SE |
| K870257 | Porex(Tm) Silicone Surgical Implants for E.N.T. · Traditional | 02/24/1987SE |
| K870182 | Porex(Tm) Malar Implant · Traditional | 02/24/1987SE |
| K870154 | Porex(Tm) Tissue ExpanderLCJ · Traditional | 02/24/1987SE |
| K863942 | Porex(Tm) Nose ProsthesisFZE · Traditional | 10/24/1986SE |
| K863941 | Porex(Tm) Prosthesis, Chin, InternalFWP · Traditional | 10/24/1986SE |
| K863939 | Porex(Tm) Ear ProsthesisFZD · Traditional | 10/24/1986SE |
Questions and answers
When was Porex Nerve Locator cleared by the FDA?
Porex Nerve Locator (K872791) received a 510(k) decision of Substantially Equivalent on October 20, 1987, 98 days after the submission was received.
What is the product code of K872791?
The FDA product code is ETN – Stimulator, Nerve, a Class II (moderate risk) device regulated under 21 CFR 874.1820.