510(k) K171807
K171807 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "ES2 Neuromonitoring Accessory Instruments". The FDA issued a decision of Substantially Equivalent on July 18, 2017. The device falls under product code PDQ (Neurosurgical Nerve Locator), a Class II device regulated under 21 CFR 874.1820. Stryker Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2017
- Date Received
- June 19, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurosurgical Nerve Locator
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- NE
- Submission Type
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.