DeviceClearance

Product code HAE— Neurology

Rebellion, Phantom Multi-Bite Kerrison Rongeur

Classification name
Rongeur, Manual
Device class
Class 2
Regulation
21 CFR 882.4840
Advisory panel
Neurology
Total cleared
36
First cleared
Most recent

Market context for product code HAE

FDA has cleared 36 devices under product code HAE between 1988 and 2025, filed by 27 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 HAE

Recent clearances under product code HAE

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