Who else makes this device?

Name: Flex-Ez Guidewire
Brand: Flex-Ez Guidewire

Gastroenterology & Urology › TherapeuticCatheter, Ureteral, Gastro-Urology

Flex-Ez Guidewire

A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interventional device (e.g., a stent or dilator) within an endoscope lumen into the gastrointestinal…

Registry build 21.09.26

A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interventional device (e.g., a stent or dilator) within an endoscope lumen into the gastrointestinal (GI) tract or the tracheobronchial tree. This is a single-use device

4manufacturers in China registered for this device type

3catalogue numbers in this listing

1510(k) clearance

1recall

Who Else Makes It

Concentrated in Jiangsu (1), Guangdong (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EYB
Manufacturer	City	Province	Registered as	Device types
Well Lead Medical Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	46
Well Lead Medical (Hainan) Co., Ltd.	Haikou	Hainan	Contract manufacturer	3
Amsino Medical (Kunshan) Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	53
Amsino Medical (Shanghai) Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	22

Record

Regulatory record for Flex-Ez Guidewire
Listed by	Hobbs Medical, Inc., United States
FDA product code	EYB
Device type	Catheter, Ureteral, Gastro-Urology
Device class	Class 2
Regulation	21 CFR 876.5130
Establishment	Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer
510(k)	K914358
Record published	2016-09-21
Record revised	2025-12-22 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
Distribution end date	2025-12-05

Catalogue Numbers

Catalogue numbers for Flex-Ez Guidewire
Catalogue number	Size	Status
3412		Withdrawn
3410		Withdrawn
3406		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Coloplast	Coloplast A/S	60
Porges Coloplast	Coloplast A/S	32
Bard® Woven Ureteral Catheter	C.R. Bard, Inc.	31
Pigtail	Cook Incorporated	18
Sof-Flex	Cook Incorporated	11
AMSure® Red Rubber Urethral Catheter	Amsino Medical Inc.	11
Medline	Medline Industries, Inc.	11
Red Rubber Urethral Catheters	Dynarex Corp.	9
Bard® Polyurethane Ureteral Catheters, Open Tip	C.R. Bard, Inc.	9
TruCath	HR Pharmaceuticals Inc.	8
Cook	Cook Incorporated	4
Flexi-Tip	Cook Incorporated	4

Showing 12 of 38. All products under Catheter, Ureteral, Gastro-Urology

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K914358	1991-11-19

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Flex-Ez Guidewire
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Hobbs Medical, Inc.	510(k) number	2022-07-29	Class II	Process control	Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot	32 units

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.