Product code GZK— Neurology
BALL RECORDING ELECTRODE/STIMULATION PROBE
- Classification name
- Electrode, Nasopharyngeal
- Device class
- Class 2
- Regulation
- 21 CFR 882.1340
- Advisory panel
- Neurology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code GZK
FDA has cleared devices under product code GZK between 1983 and 2003, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2003
- 1983
Top applicants under product code GZK
Recent clearances under product code GZK
Data sourced from openFDA. This site is unofficial and independent of the FDA.