DeviceClearance

Product code HBF— Neurology

DISPOSABLE PERFORATOR

Classification name
Drills, Burrs, Trephines & Accessories (Compound, Powered)
Device class
Class 2
Regulation
21 CFR 882.4305
Advisory panel
Neurology
Total cleared
19
First cleared
Most recent

Market context for product code HBF

FDA has cleared 19 devices under product code HBF between 1979 and 2026, filed by 11 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 HBF

Adverse events under product code HBF

product code HBF
Injury
587
Malfunction
621
Other
1
Total
1,209

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 HBF

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