ES2 Neuromonitoring Accessory Instruments
FDA 510(k) K171807 · Stryker Corporation
510(k) numberK171807
Submission
- Device name
- ES2 Neuromonitoring Accessory Instruments
- Applicant
- Stryker Corporation
Allendale, NJ, US - Received
- June 19, 2017
- Decision date
- July 18, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDQ – Neurosurgical Nerve Locator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1820
- Specialty
- Ear, Nose, Throat
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
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Questions and answers
When was ES2 Neuromonitoring Accessory Instruments cleared by the FDA?
ES2 Neuromonitoring Accessory Instruments (K171807) received a 510(k) decision of Substantially Equivalent on July 18, 2017, 29 days after the submission was received.
What is the product code of K171807?
The FDA product code is PDQ – Neurosurgical Nerve Locator, a Class II (moderate risk) device regulated under 21 CFR 874.1820.