DeviceClearance

Product code JXL— Neurology

BITE BLOCK

Classification name
Block, Bite
Device class
Class 2
Regulation
21 CFR 882.5070
Advisory panel
Neurology
Total cleared
28
First cleared
Most recent

Market context for product code JXL

FDA has cleared 28 devices under product code JXL between 1976 and 2023, filed by 25 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 JXL

Recent clearances under product code JXL

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