Multi-Functional Electrosurgical Knife— 510(k) K212999

Substantially Equivalent

Anrei Medical (Hangzhou) Co., Ltd.

FDA 510(k) clearance K212999 for Multi-Functional Electrosurgical Knife, Substantially Equivalent on 2022-03-21. Applicant: Anrei Medical (Hangzhou) Co., Ltd..

Clearance details

Applicant: Anrei Medical (Hangzhou) Co., Ltd.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-20
Decision date: 2022-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.