K181545

Substantially Equivalent

Hysteroscope System

Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
Product code: HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2018-06-12
Decision date: 2019-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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