Data / Medical devices / China / Zhejiang Shuyou Surgical Instrument Co., Ltd

Zhejiang Shuyou Surgical Instrument Co., Ltd: FDA-registered device maker in Huzhou Zhejiang, China, 2 510(k) clearances

Name: Zhejiang Shuyou Surgical Instrument Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Zhejiang Shuyou Surgical Instrument Co., Ltd is registered with the FDA (registration 3007728276) in Huzhou Zhejiang, China. It lists 14 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 7, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3007728276
Address: 3689#, East Yangguang Avenue, Dipu street Anji, Huzhou Zhejiang, China, 313300
Owner or operator: Zhejiang Shuyou Surgical Instrument Co., Ltd (10028980)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: March 25, 2009
Registered through: 2027

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Exhaust, Surgical	FYD	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Contract manufacturer	accessdata.fda.gov
Curette, Suction, Endometrial (And Accessories)	HHK	2	Contract manufacturer	accessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)	HGI	2	Contract manufacturer	accessdata.fda.gov
Electrosurgical Patient Return Electrode	ODR	2	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Contract manufacturer	accessdata.fda.gov
Remover, Intrauterine Device, Contraceptive, Hook-Type	HHF	1	Manufacturer	accessdata.fda.gov
Scale, Surgical Sponge	FQA	1	Contract manufacturer	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Manufacturer	accessdata.fda.gov
Sound, Uterine	HHM	1	Manufacturer	accessdata.fda.gov
Tenaculum, Uterine, Exempt	PUA	2	Contract manufacturer	accessdata.fda.gov
Tube, Smoke Removal, Endoscopic	FCZ	1	Manufacturer	accessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, Laparoscopic	NKC	1	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
April 7, 2026	K260466	Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)	GEI	Substantially Equivalent	Zhejiang shuyou Surgical Instrument Co., Ltd.	accessdata.fda.gov
February 10, 2005	K040780	ELECTROSURGICAL PENCILS	GEI	Substantially Equivalent	Hangzhou Shuyou Medical Instrument Company, Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 7, 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.