Product code HBO— Neurology

ACRA-CUT

Classification name
Clip, Scalp
Device class
Class 2
Regulation
21 CFR 882.4150
Advisory panel
Neurology
Total cleared
11
First cleared
Most recent

Market context for product code HBO

FDA has cleared 11 devices under product code HBO between 1988 and 2026, filed by 10 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

Top applicants under product code HBO

Recent clearances under product code HBO

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