DeviceClearance

Product code BXN— Anesthesiology

ACCELOGRAPH

Classification name
Stimulator, Nerve, Battery-Powered
Device class
Class 2
Regulation
21 CFR 868.2775
Advisory panel
Anesthesiology
Total cleared
63
First cleared
Most recent

Market context for product code BXN

FDA has cleared 63 devices under product code BXN between 1976 and 2022, filed by 40 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 BXN

Adverse events under product code BXN

product code BXN
Other
1
Total
1

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 BXN

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