Disposable Automatic Core Biopsy Instrument— 510(k) K212284

Substantially Equivalent

Suzhou Leapmed Healthcare Corporation

FDA 510(k) clearance K212284 for Disposable Automatic Core Biopsy Instrument, Substantially Equivalent on 2021-11-10. Applicant: Suzhou Leapmed Healthcare Corporation.

Clearance details

Applicant: Suzhou Leapmed Healthcare Corporation
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2021-07-21
Decision date: 2021-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.