What is FDA product code OCY?

To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.

Gastroenterology & Urology › DiagnosticEndoscopic Guidewire, Gastroenterology-Urology

Coons-Bentson

Name: Coons-Bentson
Brand: Coons-Bentson

Coons-Bentson Movable Core Hydrophilic Wire Guide

Registry build 21.09.26

21manufacturers in China registered for this device type

4catalogue numbers in this listing

9recalls on this code

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 Coons-Bentson
Listed by	Cook Incorporated, United States
FDA product code	OCY
Device type	Endoscopic Guidewire, Gastroenterology-Urology
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published	2016-09-24
Record revised	2024-12-23 (version 4)

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
Storage	Special storage condition: Store in dark, dry, cool place.
Distribution end date	2017-08-17

Catalogue Numbers

Catalogue numbers for Coons-Bentson
Catalogue number	Size	Status
G14685		In distribution
G14619		In distribution
G15591		Withdrawn
G15564		Withdrawn

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

Recalls

9 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2022-08-16	Class II	Under Investigation by firm	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.	56 US; 1033 OUS
2019-01-04	Class II	Process control	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.	1079	2020-05-29
2019-01-04	Class II	Process control	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.	13388 total	2020-05-29
2019-01-04	Class II	Process control	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.	13388 total	2020-05-29
2019-01-04	Class II	Process control	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.	13388 total	2020-05-29
2019-01-04	Class II	Process control	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.	3929	2020-05-29
2019-01-04	Class II	Process control	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.	146	2020-05-29
2019-01-04	Class II	Process control	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.	13388 total	2020-05-29
2019-01-04	Class II	Process control	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.	15	2020-05-29

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.