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Yangzhou Fartley Medical Instrument Technology Co., Ltd: FDA-registered device maker in Yangzhou Jiangsu, China, 8 510(k) clearances

Name: Yangzhou Fartley Medical Instrument Technology Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Yangzhou Fartley Medical Instrument Technology Co., Ltd is registered with the FDA (registration 3011193403) in Yangzhou Jiangsu, China. It lists 23 device types. The FDA files 8 510(k) clearances under its listings, the newest dated May 28, 2026. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3011193403
Address: Beizhou Road, Lidian Town, Guangling District, Yangzhou Jiangsu, China, 225106
Owner or operator: Yangzhou Fartley Medical Instrument Technology Co., Ltd (10047116)
Roles: Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
First device listed: July 2, 2014
Registered through: 2027
Brand names listed: Bedside Cleaning Sponge with 1000ml tray, Bedside Cleaning Sponge with enzymatic cleaner and tray, CO2 Adapter, Caesar Alligator RAT TOOTH GRASPING FORCEPS, Clean Connecting Tube, Cold AcuSnare Polypectomy Snare, Disposable Biopsy Forceps,Non-Electric, Disposable Bite Block and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Colonoscope And Accessories, Flexible/Rigid	FDF	2	Manufacturer	accessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2	Manufacturer	accessdata.fda.gov
Endoscope Channel Accessory	ODC	2	Manufacturer	accessdata.fda.gov
Endoscope Introducer Kit	NWU	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	PTS	2	Manufacturer	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Manufacturer	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gastroscope And Accessories, Flexible/Rigid	FDS	2	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Specification developer	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Manufacturer	accessdata.fda.gov
Holder, Camera, Surgical	FXR	1	Manufacturer	accessdata.fda.gov
Lubricant, Patient	KMJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Snare, Flexible	FDI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Snare, Non-Electrical	FGX	1	Manufacturer	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, Laparoscopic	NKC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 28, 2026	K260423	Disposable Endoscopic Distal Attachments	FDF	Substantially Equivalent	Yangzhou Fartley Medical Instrument Technology Co., Ltd.	accessdata.fda.gov
June 20, 2025	K250732	Disposable Endoscopy Valve Set	ODC	Substantially Equivalent	Yangzhou Fartley Medical Instrument Technology Co., Ltd.	accessdata.fda.gov
July 31, 2023	K230004	Disposable Hemoclip	PKL	Substantially Equivalent	Yangzhou Fartley Medical Instrument Technology Co., Ltd.	accessdata.fda.gov
November 21, 2022	K222980	Pentax Medical Valve Set	ODC	Substantially Equivalent	Yangzhou Fartley Medical Instrument Technology Co., Ltd.	accessdata.fda.gov
September 27, 2022	K220785	Clean Connecting Tube	OCX	Substantially Equivalent	Yangzhou Fartley Medical Instrument Technology Co., Ltd.	accessdata.fda.gov
August 19, 2022	K220292	Disposable Endoscope Injection Needle	FBK	Substantially Equivalent	Yangzhou Fartley Medical Instrument Technology Co., Ltd.	accessdata.fda.gov
June 27, 2022	K220790	Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare	FDI	Substantially Equivalent	Yangzhou Fartley Medical Instrument Technology Co., Ltd.	accessdata.fda.gov
June 17, 2022	K220210	Disposable Endoscopy Adapter Set	ODC	Substantially Equivalent	Yangzhou Fartley Medical Instrument Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.