FDA Product Code HBF: Drills, Burrs, Trephines & Accessories (compound, Powered)
Leading manufacturers include Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. and Evonos GmbH & Co. KG.
18
Total
18
Cleared
125d
Avg days
1979
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Drills, Burrs, Trephines & Accessories (compound, Powered) Devices (Product Code HBF)
18 devices
Cleared
Mar 06, 2024
evoDrill Cranial Perforator
Evonos GmbH & Co. KG
Neurology
296d
Cleared
Jun 20, 2022
NeuroLine Disposable Cranial Perforator with Hudson end
Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.
Neurology
264d
About Product Code HBF - Regulatory Context
510(k) Submission Activity
18 total 510(k) submissions under product code HBF since 1979, with 18 receiving FDA clearance (average review time: 125 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
HBF devices are reviewed by the Neurology panel. Browse all Neurology devices →