Single Use Rotatable and Repositionable Hemoclip— 510(k) K201771

Substantially Equivalent

Anrei Medical (Hangzhou) Co., Ltd.

FDA 510(k) clearance K201771 for Single Use Rotatable and Repositionable Hemoclip, Substantially Equivalent on 2020-10-19. Applicant: Anrei Medical (Hangzhou) Co., Ltd..

Clearance details

Applicant: Anrei Medical (Hangzhou) Co., Ltd.
Product code: Code PKL
Advisory panel: Gastroenterology, Urology
Date received: 2020-06-29
Decision date: 2020-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code PKL

product code PKL

Death: 9
Injury: 489
Malfunction: 4,698
Other: 1
Total: 5,197

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.