DeviceClearance

Product code JXG— Neurology

Smart External Drain (SED) System

Classification name
Shunt, Central Nervous System And Components
Device class
Class 2
Regulation
21 CFR 882.5550
Advisory panel
Neurology
Total cleared
259
First cleared
Most recent

Market context for product code JXG

FDA has cleared 259 devices under product code JXG between 1976 and 2026, filed by 60 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 JXG

Adverse events under product code JXG

product code JXG
Death
76
Injury
5,632
Malfunction
2,230
Other
4
Total
7,942

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 JXG

1–100 of 259

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