TELIGEN System Peripheral Motor Nerve Stimulation Indications
FDA 510(k) K223438 · Medos International SARL
510(k) numberK223438
Submission
- Device name
- TELIGEN System Peripheral Motor Nerve Stimulation Indications
- Applicant
- Medos International SARL
Le Locle, CH - Received
- November 14, 2022
- Decision date
- February 10, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 TELIGEN System Peripheral Motor Nerve Stimulation Indications cleared by the FDA?
TELIGEN System Peripheral Motor Nerve Stimulation Indications (K223438) received a 510(k) decision of Substantially Equivalent on February 10, 2023, 88 days after the submission was received.
What is the product code of K223438?
The FDA product code is PDQ – Neurosurgical Nerve Locator, a Class II (moderate risk) device regulated under 21 CFR 874.1820.