Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007728276

FEI Number

3007728276

Entity Name

Zhejiang Shuyou Surgical Instrument Co., Ltd

City/State/Country

Huzhou Zhejiang, CN

Establishment Address

3689#, East Yangguang Avenue, Dipu street Anji, Huzhou Zhejiang 313300, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Zhejiang Shuyou Surgical Instrument Co., Ltd (Owner Number: 10028980)

Owner / Operator Contact Address

3689#, East Yangguang Avenue, Dipu Street Anji, Huzhou, CN-ZJ 313300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2026-04-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-04-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-03-22
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	Class 1	876.1500	2014-02-06
HHK	Curette, Suction, Endometrial (And Accessories)	Obstetrics/Gynecology	Class 2	884.1175	2014-01-28
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-01-09
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2018-08-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-07-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-03-25
PUA	Tenaculum, Uterine, Exempt	Obstetrics/Gynecology	Class 2	884.4530	2022-09-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-05-05
ODR	Electrosurgical Patient Return Electrode	General, Plastic Surgery	Class 2	878.4400	2010-01-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-01-04
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2023-03-17
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2014-01-28
FQA	Scale, Surgical Sponge	General Hospital	Class 1	880.2740	2018-05-04
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2009-08-28
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2022-04-25

Official Correspondent

Ying Su

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Zhejiang Shuyou Surgical Instrument Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0008-2013	Gynex Corporation	2	Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "*GYNEX* Electrode Handpiece, Foot Activated* Manufactured for GYNEX*" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.

Similar Registrations

Registration Number	Establishment Name	Location
3008571754	Purple Surgical Manufacturing Limited	Taunton Somerset, GB
3004530184	ANDERSEN CALEDONIA LTD	Bellshill Scotland, GB
3012345110	Novadaq Technologies ULC	Burnaby British Columbia, CA
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US
9610773	OLYMPUS WINTER & IBE GMBH	HAMBURG, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007728276. Last updated year: 2026. Please use registration number 3007728276 when referencing this establishment in official correspondence.