Disposable Coaxial Biopsy Needle— 510(k) K212822

Substantially Equivalent

Suzhou Leapmed Healthcare Corporation

FDA 510(k) clearance K212822 for Disposable Coaxial Biopsy Needle, Substantially Equivalent on 2022-07-06. Applicant: Suzhou Leapmed Healthcare Corporation.

Clearance details

Applicant: Suzhou Leapmed Healthcare Corporation
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-03
Decision date: 2022-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.