Guidewire

The Guidewire is used to provide access to GI tract for the purpose of passing or exchanging endoscopic accessories.

Registry build 21.09.26
21manufacturers in China registered for this device type
8catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Zhejiang (7), Guangdong (3). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OCY
Manufacturer City Province Registered as Device types
Changzhou Jiuhong Medical Instrument Co., Ltd. Changzhou Jiangsu Contract manufacturer 10
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Beijing Zksk Technology Co., Ltd. Beijing Beijing Contract manufacturer 38
Zhejiang Chuangxiang Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Jiana Sterilization Technology (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 23
Shenzhen Hugemed Medical Technical Development Co., Ltd. Shenzhen Guangdong Manufacturer 22
Jiangsu Vedkang Medical Science and Technology Co., Ltd. Changzhou Jiangsu Manufacturer 20
Alton Shanghai Medical Instruments Co Ltd Shanghai Shanghai Complaint-file establishment 20
Hangzhou AGS MedTech Co., Ltd. Hangzhou Zhejiang Repacker / relabeller 19
Scivita Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 19

Showing 12 of 21. All 21 manufacturers in China registered for Endoscopic Guidewire, Gastroenterology-Urology

Record

Regulatory record for Guidewire
Listed by Taewoongmedical.co., Ltd.
FDA product code OCY
Device type Endoscopic Guidewire, Gastroenterology-Urology
Device class Class 2
Regulation 21 CFR 876.1500
Premarket notification Exempt
Record published 2026-04-24

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 10

Catalogue Numbers

Catalogue numbers for Guidewire
Catalogue number Size Status
GW3-45S In distribution
GW2-26A In distribution
GW2-26S In distribution
GW3-26S In distribution
GW3-45A In distribution
GW2-45S In distribution
GW3-26A In distribution
GW2-45A In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Single Use Urinary Guidewire Zhejiang Chuangxiang Medical Technology Co., Ltd. 332
Single Use Guidewire Zhejiang Chuangxiang Medical Technology Co., Ltd. 194
Roadrunner Cook Incorporated 44
Cook Cook Incorporated 43
Jagwire Boston Scientific Corporation 35
Ercp Heraeus Medical Components, SRL 32
Hydrophilic Guidewire for Urinary Tract Shenzhen Hainwise Medical Technology Co., Ltd. 24
Acrobat Cook Incorporated 20
Amplatz Cook Incorporated 19
RevoWave™ Piolax Medical Devices, Inc. 19
Zksk Beijing Zksk Technology Co., Ltd. 18
Tracer Metro Cook Incorporated 17

Showing 12 of 60. All products under Endoscopic Guidewire, Gastroenterology-Urology

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer