Pentax Medical Valve Set— 510(k) K222980

Name: FDA 510(k) clearance K222980
Creator: U.S. Food and Drug Administration
Published: 2022-11-21

Substantially Equivalent

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

FDA 510(k) clearance K222980 for Pentax Medical Valve Set, Substantially Equivalent on 2022-11-21. Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-09-28
Decision date: 2022-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODC

view all

K252933 — DYNE PORT2026-06-12
K250145 — Biopsy Port Adapter2025-10-17
K252910 — Orca Air/Water and Suction Valves2025-10-09
K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)2025-07-16
K250732 — Disposable Endoscopy Valve Set2025-06-20

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

view all

K260423 — Disposable Endoscopic Distal Attachments2026-05-28
K230004 — Disposable Hemoclip2023-07-31
K220785 — Clean Connecting Tube2022-09-27
K220292 — Disposable Endoscope Injection Needle2022-08-19
K220790 — Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare2022-06-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.