Disposable Endoscopic Distal Attachments— 510(k) K260423

Name: FDA 510(k) clearance K260423
Creator: U.S. Food and Drug Administration
Published: 2026-05-28

Substantially Equivalent

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

FDA 510(k) clearance K260423 for Disposable Endoscopic Distal Attachments, Substantially Equivalent on 2026-05-28. Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Product code: Code FDF
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2026-02-09
Decision date: 2026-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FDF

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K260503 — Triton 1 System2026-09-03
K261015 — Solo Scope Colonoscope System2026-08-21
K261587 — Insufflation Retention Device (IRD) (11173-325-101)2026-07-02
K252457 — Disposable Distal End Tape Hood2026-01-30
K244029 — ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)2025-09-24

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

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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
K220292 — Disposable Endoscope Injection Needle2022-08-19

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.