ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)— 510(k) K240401

Substantially Equivalent

Origyn Medical Technology (Hangzhou) Co., Ltd.

FDA 510(k) clearance K240401 for ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US), Substantially Equivalent on 2024-07-26. Applicant: Origyn Medical Technology (Hangzhou) Co., Ltd..

Clearance details

Applicant: Origyn Medical Technology (Hangzhou) Co., Ltd.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2024-02-09
Decision date: 2024-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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.