Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017262662

FEI Number

3017262662

Entity Name

Wuxi Goals Medical Technology Co., Ltd.

City/State/Country

Yixing Jiangsu, CN

Establishment Address

South Area of South Industrial Concentration Zone, Wanshi Town, Yixing Jiangsu 214212, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Wuxi Gaols Medical Technology Co., Ltd. (Owner Number: 10073607)

Owner / Operator Contact Address

South Industrial Concentration Zone, Wanshi Town, Yixing, CN-JS 214212, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Specimen Containers Disposable Biopsy Forceps Navajo PTA Balloon Dilation Catheter Elastic Bandage Stretch Bandage Undercast Selethru PTCA Balloon Dilatation Catheter Sterile Disposable Centrifuge Tube Disposable Polyp Traps Nova Light Source Pencil Disposable Cold Snares KSC DB Plus Acupuncture Needles AcuZone Intradermal Needles AcuZone Press Tack Needles AcuZone Acupuncture Needles Hydra Water bottle cap Hydra Irrigation water bottle cap tubing Hydra Water Jet Connector Orange Surgical Instruments Disposable Endoscope Valves Set A Disposable Retrieval Baskets Disposable Bite Blocks UrsaTM Angiographic Catheter - 16 new models Sonosure Sonohystergraphy & Endometrial Sampling Device Rescue

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2020-05-12
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2020-05-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-05-12
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-09-13
LGF	Component, Cast	Orthopedic	Class 1	888.5940	2024-09-13
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2020-05-12
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2020-05-12
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2020-05-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-05-12
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2020-05-12
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2020-05-12
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2020-05-12
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2020-05-12
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2020-05-12
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-05-12
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2020-05-12
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2020-05-12
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2020-05-12
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2020-05-12
HFE	Brush, Endometrial	Obstetrics/Gynecology	Class 2	884.1100	2020-05-12
PGK	Cannula, Injector, Uterine, Endometrial Biopsy	Obstetrics/Gynecology	Class 2	884.4530	2020-05-12
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2020-05-12

Official Correspondent

Liu Wen Yi

US Agent Details

Dennis Xu Email: ybx99@yahoo.com Phone: (919) 8590478

Related Public Records

Same Entity

Wuxi Gaols Medical Technology 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
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Similar Registrations

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3027605742	Xiamen Zhiyuan Medical Technology Co., Ltd.	XIAMEN Fujian, CN
2320762	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
3010420046	CITOTEST Labware Manufacturing CO., LTD.	Haimen Jiangsu, CN
3044466317	MEDINOVA GROUP CO.	Laguna Beach, CA, US
1055236	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017262662. Last updated year: 2026. Please use registration number 3017262662 when referencing this establishment in official correspondence.