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Zhejiang Chuangxiang Medical Technology Co., Ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 14 510(k) clearances

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

Zhejiang Chuangxiang Medical Technology Co., Ltd. is registered with the FDA (registration 3013460719) in Hangzhou Zhejiang, China. It lists 27 device types. The FDA files 14 510(k) clearances under its listings, the newest dated September 11, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013460719
Address: Room 101-1, 201-1, 301, 401, Building 50, No.650 Hongfeng Road, Donghu Street, Linping District, Hangzhou Zhejiang, China, 311100
Owner or operator: Zhejiang Chuangxiang Medical Technology Co., LTD. (10053736)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: January 5, 2017
Registered through: 2026
Brand names listed: Air/Water Bottle Tubing, CO2 Source Tubing, Chuangxiang, Cleaning Brush, Colonoscopy holding device, Disposable Biopsy Valve, Disposable Bite Block, Disposable Ureteral Stents (Types C and D), Disposable Valve Sets; MD-A-AW01; MD-B-AW01; Sterilization, endoscopic Compatibility:Olympus 140/160/180/190/240/260 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
Bottle, Collection, Vacuum	KDQ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Clamp, Surgical, General & Plastic Surgery	GDJ	1	Manufacturer	accessdata.fda.gov
Dilator, Urethral	KOE	2	Manufacturer	accessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2	Manufacturer	accessdata.fda.gov
Endoscope Channel Accessory	ODC	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Manufacturer	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Endoscopic Cytology Brush	FDX	2	Manufacturer	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered	OCZ	2	Manufacturer	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	PTS	2	Manufacturer	accessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-Urology	OCY	2	Manufacturer	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Manufacturer	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Hysteroscope Accessories	NWW	1	Manufacturer	accessdata.fda.gov
Insufflator, Automatic Carbon-Dioxide For Endoscope	FCX	2	Manufacturer	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Lubricant, Patient	KMJ	1	Repackager or relabeler	accessdata.fda.gov
Needle, Catheter	GCB	1	Manufacturer	accessdata.fda.gov
Snare, Flexible	FDI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Snare, Non-Electrical	FGX	1	Manufacturer	accessdata.fda.gov
Stent, Ureteral	FAD	2	Manufacturer	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	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
September 11, 2026	K260410	Single Use Ureteral Access Sheath	FED	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov
March 6, 2026	K253132	Single use stone retrieval balloons	FGE	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov
February 20, 2026	K251890	Disposable Ureteral Stents	FAD	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov
November 21, 2023	K230773	Endoscopy Irrigation Tubing	OCX	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov
September 8, 2023	K231471	Air/Water Bottle Tubing, CO2 Source Tubing	OCX	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov
July 28, 2022	K220063	Single Use Cytology Brush	FDX	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov
May 27, 2022	K212669	Single Use Hemoclip	PKL	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov
May 25, 2022	K220065	Single Use Ureteral Access Sheath	FED	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov
February 23, 2022	K212668	Sclerotherapy Needle	FBK	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov
March 27, 2020	K191900	Single Use Grasping Forceps	OCZ	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov
December 30, 2019	K192258	Disposable Valve Sets	ODC	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov
May 14, 2018	K173758	Disposable Biopsy Valve	OCX	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov
March 20, 2018	K172762	Single Use Hemoclip	PKL	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov
March 7, 2018	K172758	Rotatable Snares, Non-Rotatable Snares	FDI	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 11, 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.