FDA Product Code HBG: Drills, Burrs, Trephines & Accessories (manual)
Leading manufacturers include Pudenz-Schulte Medical Research Corp., Medtronic Xomed, Inc. and Synthes USA Products, 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
Cleared
Nov 21, 2025
LEGACY
Phasor Health, LLC
Neurology
86d
Cleared
Jan 18, 2017
Taps for Resorbable Screws
Synthes USA Products, LLC
Neurology
399d
Cleared
Oct 18, 2002
FRAMELOCK
Medtronic Xomed, Inc.
Neurology
88d
Cleared
Dec 30, 1991
PS MEDICAL VENTRICULOSTOMY KIT
Pudenz-Schulte Medical Research Corp.
Neurology
19d
Cleared
Oct 03, 1990
PS MEDICAL CRANIAL HAND DRILL
Pudenz-Schulte Medical Research Corp.
Neurology
16d
Cleared
May 05, 1989
NEUROSURGICAL DRILLS: STILLE, HUDSON
Zinnanti Surgical Instruments, Inc.
Neurology
24d
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 510(k) Review Time - HBG Product Code
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 →