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

Name: FDA 510(k) clearance K220790
Creator: U.S. Food and Drug Administration
Published: 2022-06-27

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.. Device class: 2.

Clearance details

Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Product code: Code FDI
Device class: Class 2
Regulation: 21 CFR 876.4300
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 ↗

Recent devices under product code FDI

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K251692 — Advanced Tissue Resection Device2026-02-21
K221713 — Polypectomy Snare2023-03-03
K220846 — CORE-SNARE2022-11-21
K220089 — Disposable Polyp Snare2022-09-22
K213222 — Disposable Polypectomy Snare2022-06-06

More clearances from Yangzhou Fartley Medical Instrument Technology Co., Ltd.

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K260423 — Disposable Endoscopic Distal Attachments2026-05-28
K250732 — Disposable Endoscopy Valve Set2025-06-20
K230004 — Disposable Hemoclip2023-07-31
K222980 — Pentax Medical Valve Set2022-11-21
K220785 — Clean Connecting Tube2022-09-27

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.