Montgomery Nerve Stimulator
FDA 510(k) K880720 · Boston Medical Products, Inc.
510(k) numberK880720
Submission
- Device name
- Montgomery Nerve Stimulator
- Applicant
- Boston Medical Products, Inc.
Waltham, MA, US - Received
- February 23, 1988
- Decision date
- May 20, 1988
- 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 |
|---|---|---|
| K091135 | Rutter Supra Stomal StentsFWN · Traditional | 09/14/2009SE |
| K972317 | Montgomery Thyroplasty Implant SystemMIX · Traditional | 09/18/1997SE |
| K972459 | Rhinocell Nasal PackingsEMX · Traditional | 08/04/1997SE |
| K972096 | Bivalve Nasal SplintLYA · Traditional | 07/15/1997SE |
| K972078 | Post-Stop Epistaxis CatheterEMX · Traditional | 07/10/1997SE |
| K972092 | Nasal Airway SplintLYA · Traditional | 07/08/1997SE |
| K972151 | Doyle Combo Nasal Airway SplintLYA · Traditional | 07/07/1997SE |
| K972082 | Custom Nasal SplintLYA · Traditional | 07/03/1997SE |
| K972060 | Nasal Septal ButtonLFB · Traditional | 07/03/1997SE |
| K972077 | Epi-Stop Epistaxis CatheterEMX · Traditional | 06/26/1997SE |
Questions and answers
When was Montgomery Nerve Stimulator cleared by the FDA?
Montgomery Nerve Stimulator (K880720) received a 510(k) decision of Substantially Equivalent on May 20, 1988, 87 days after the submission was received.
What is the product code of K880720?
The FDA product code is ETN – Stimulator, Nerve, a Class II (moderate risk) device regulated under 21 CFR 874.1820.