DeviceClearance

Product code HIF— Obstetrics/Gynecology

EVA15 insufflator

Classification name
Insufflator, Laparoscopic
Device class
Class 2
Regulation
21 CFR 884.1730
Advisory panel
Obstetrics/Gynecology
Total cleared
179
First cleared
Most recent

Market context for product code HIF

FDA has cleared 179 devices under product code HIF between 1978 and 2026, filed by 102 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 HIF

Adverse events under product code HIF

product code HIF
Death
19
Injury
578
Malfunction
5,639
Total
6,236

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 HIF

1–100 of 179

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