Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)— 510(k) K190797

Substantially Equivalent

Reed Medical (Zhejiang) Co., Ltd.

FDA 510(k) clearance K190797 for Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01), Substantially Equivalent on 2019-11-18. Applicant: Reed Medical (Zhejiang) Co., Ltd..

Clearance details

Applicant: Reed Medical (Zhejiang) Co., Ltd.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2019-03-28
Decision date: 2019-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pinghu, 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.