DeviceClearance

Product code HIH— Obstetrics/Gynecology

Endosee System

Classification name
Hysteroscope (And Accessories)
Device class
Class 2
Regulation
21 CFR 884.1690
Advisory panel
Obstetrics/Gynecology
Total cleared
173
First cleared
Most recent

Market context for product code HIH

FDA has cleared 173 devices under product code HIH between 1980 and 2026, filed by 88 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 HIH

Adverse events under product code HIH

product code HIH
Death
18
Injury
973
Malfunction
5,071
Other
1
Total
6,063

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 HIH

1–100 of 173

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