ES2 Neuromonitoring Accessory Instruments
FDA 510(k) K140400 · Stryker Corporation
510(k) numberK140400
Submission
- Device name
- ES2 Neuromonitoring Accessory Instruments
- Applicant
- Stryker Corporation
Allendale, NJ, US - Received
- February 18, 2014
- Decision date
- July 1, 2014
- 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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| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)ETN · Traditional | Medtronic Xomed, Inc. | 08/30/2023SE |
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Questions and answers
When was ES2 Neuromonitoring Accessory Instruments cleared by the FDA?
ES2 Neuromonitoring Accessory Instruments (K140400) received a 510(k) decision of Substantially Equivalent on July 1, 2014, 133 days after the submission was received.
What is the product code of K140400?
The FDA product code is ETN – Stimulator, Nerve, a Class II (moderate risk) device regulated under 21 CFR 874.1820.