DeviceClearance

Product code HET— Obstetrics/Gynecology

LAPAROSCOPE

Classification name
Laparoscope, Gynecologic (And Accessories)
Device class
Class 2
Regulation
21 CFR 884.1720
Advisory panel
Obstetrics/Gynecology
Total cleared
338
First cleared
Most recent

Market context for product code HET

FDA has cleared 338 devices under product code HET between 1977 and 2025, filed by 145 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 HET

Adverse events under product code HET

product code HET
Malfunction
10,504
Total
10,504

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 HET

1–100 of 338

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