DeviceClearance

Product code HBC— Neurology

450/800 DRILL

Classification name
Motor, Drill, Electric
Device class
Class 2
Regulation
21 CFR 882.4360
Advisory panel
Neurology
Total cleared
27
First cleared
Most recent

Market context for product code HBC

FDA has cleared 27 devices under product code HBC between 1981 and 2026, filed by 16 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 HBC

Adverse events under product code HBC

product code HBC
Malfunction
4,715
Total
4,715

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 HBC

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