Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)— 510(k) K231725

Substantially Equivalent

Hunan Endoso Life Technology Co., Ltd.

FDA 510(k) clearance K231725 for Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R), Substantially Equivalent on 2023-10-16. Applicant: Hunan Endoso Life Technology Co., Ltd..

Clearance details

Applicant: Hunan Endoso Life Technology Co., Ltd.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2023-06-13
Decision date: 2023-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hunan, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.