510(k) K234124— Single Use Hemoclips

Substantially Equivalent

Promisemed Hangzhou Meditech Co., Ltd.

Clearance details

Applicant: Promisemed Hangzhou Meditech Co., Ltd.
Product code: Code PKL
Advisory panel: Gastroenterology, Urology
Date received: 2023-12-28
Decision date: 2024-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou City, CN

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.