DeviceClearance

Product code HCG— Neurology

HYDROCOIL EMBOLIC SYSTEM (HES)

Classification name
Device, Neurovascular Embolization
Device class
Class 2
Regulation
21 CFR 882.5950
Advisory panel
Neurology
Total cleared
187
First cleared
Most recent

Market context for product code HCG

FDA has cleared 187 devices under product code HCG between 1987 and 2026, filed by 39 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 HCG

Adverse events under product code HCG

product code HCG
Death
50
Injury
801
Malfunction
5,625
Total
6,476

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 HCG

1–100 of 187

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