Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare— 510(k) K220790

Substantially Equivalent

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

FDA 510(k) clearance K220790 for Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare, Substantially Equivalent on 2022-06-27. Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd..

Clearance details

Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Product code: Code FDI
Advisory panel: Gastroenterology, Urology
Date received: 2022-03-17
Decision date: 2022-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

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.