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Zhejiang Soudon Medical Technology Co.,ltd: FDA-registered device maker in Hangzhou Zhejiang, China, 5 510(k) clearances

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

Zhejiang Soudon Medical Technology Co.,ltd is registered with the FDA (registration 3025311469) in Hangzhou Zhejiang, China. It lists 9 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 8, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3025311469
Address: Room 401, Building 1, No.99, Lvzhou Road Linping Street,Linping District, Hangzhou Zhejiang, China, 311100
Owner or operator: Zhejiang Soudon Medical Technology Co.,Ltd (10087131)
Roles: Manufacturer
First device listed: January 16, 2023
Registered through: 2026
Brand names listed: Dispoasble Bite Block;Endoscopic Bite Block;Disposable Dental Pad;Disposable Mouth Guard, Dispoasble Clean Brush ;Disposable Endoscopic Cleaning Brush, Disposable Endoscope Injection Needles, Disposable Guide Wire, Disposable Hemostatic Clips, Disposable Rotatable Biopsy Forceps/Disposable Biopsy Forceps, Disposable Sphincterotome, Disposable Stone Extraction Basket and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Manufacturer	accessdata.fda.gov
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	GCA	2	Manufacturer	accessdata.fda.gov
Dislodger, Stone, Biliary	LQR	2	Manufacturer	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	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
Forceps, Biopsy, Non-Electric	FCL	1	Manufacturer	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Manufacturer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	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
May 8, 2026	K253013	Disposable Stone Retrieval Balloon Catheter	GCA	Substantially Equivalent	Zhejiang Soudon Medical Technology Co., Ltd.	accessdata.fda.gov
April 3, 2026	K253056	Disposable Stone Extraction Basket	LQR	Substantially Equivalent	Zhejiang Soudon Medical Technology Co., Ltd.	accessdata.fda.gov
January 26, 2024	K232450	Disposable Hemostatic Clips	PKL	Substantially Equivalent	Zhejiang Soudon Medical Technology Co., Ltd.	accessdata.fda.gov
November 9, 2023	K232442	Disposable Endoscope Injection Needles	FBK	Substantially Equivalent	Zhejiang Soudon Medical Technology Co., Ltd.	accessdata.fda.gov
November 7, 2023	K232476	Disposable Sphincterotome	KNS	Substantially Equivalent	Zhejiang Soudon Medical Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 8, 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.