K232003

Substantially Equivalent

Endoscopic Video Image Processor, Single-Use Video Hysteroscope

Applicant: Guangzhou Red Pine Medical Instrument Co., Ltd.
Product code: HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2023-07-06
Decision date: 2024-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, 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.