DeviceClearance

Product code HBE— Neurology

2.1 x 255mm Drill, 22mm Stop

Classification name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device class
Class 2
Regulation
21 CFR 882.4310
Advisory panel
Neurology
Total cleared
65
First cleared
Most recent

Market context for product code HBE

FDA has cleared 65 devices under product code HBE between 1987 and 2026, filed by 38 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

last 15 years

Top applicants under product code HBE

Adverse events under product code HBE

product code HBE
Injury
306
Malfunction
7,175
Other
1
Total
7,482

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code HBE

Data sourced from openFDA. This site is unofficial and independent of the FDA.