FDA Product Code HBG: Drills, Burrs, Trephines & Accessories (manual)
Leading manufacturers include Phasor Health, LLC.
17
Total
17
Cleared
90d
Avg days
1986
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Consistent review times:
86d avg (recent)
FDA 510(k) Cleared Drills, Burrs, Trephines & Accessories (manual) Devices (Product Code HBG)
17 devices
About Product Code HBG - Regulatory Context
510(k) Submission Activity
17 total 510(k) submissions under product code HBG since 1986, with 17 receiving FDA clearance (average review time: 90 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for HBG submissions have been consistent, averaging 86 days recently vs 90 days historically.
HBG devices are reviewed by the Neurology panel. Browse all Neurology devices →