510(k) K223438
K223438 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "TELIGEN System Peripheral Motor Nerve Stimulation Indications". The FDA issued a decision of Substantially Equivalent on February 10, 2023. The device falls under product code PDQ (Neurosurgical Nerve Locator), a Class II device regulated under 21 CFR 874.1820. Medos International SARL has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2023
- Date Received
- November 14, 2022
- Clearance Type
- Traditional
- 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.