DeviceClearance

Product code HIG— Obstetrics/Gynecology

AQUASENS FLUID MONITORING SYSTEM

Classification name
Insufflator, Hysteroscopic
Device class
Class 2
Regulation
21 CFR 884.1700
Advisory panel
Obstetrics/Gynecology
Total cleared
57
First cleared
Most recent

Market context for product code HIG

FDA has cleared 57 devices under product code HIG between 1984 and 2026, filed by 33 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 HIG

Adverse events under product code HIG

product code HIG
Death
8
Other
2
Total
10

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 HIG

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