Hercules

Hercules 3 Stage Wireguided Balloon Esophageal - Pyloric - Colonic

Registry build 21.09.26
9manufacturers in China registered for this device type
10catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KNQ
Manufacturer City Province Registered as Device types
Changzhou Health Microport Medical Device Co., Ltd. Changzhou Jiangsu Contract manufacturer 10
Changzhou Jiuhong Medical Instrument Co., Ltd. Changzhou Jiangsu Contract manufacturer 10
Jiangsu Changmei Medtech Co., Ltd. Changzhou Jiangsu Contract manufacturer 8
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Jiangsu Vedkang Medical Science and Technology Co., Ltd. Changzhou Jiangsu Manufacturer 20
Hangzhou AGS MedTech Co., Ltd. Hangzhou Zhejiang Repacker / relabeller 19
Jiangsu Grit Medical Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 13
Jiangsu Power-Endo Medical Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 7
LEO Medical Co., Ltd. Changzhou Jiangsu Manufacturer 4

Record

Regulatory record for Hercules
Listed by Cook Incorporated, United States
FDA product code KNQ
Device type Dilator, Esophageal
Device class Class 2
Regulation 21 CFR 876.5365
Establishment Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2016-09-24
Record revised 2024-12-23 (version 3)

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.

Catalogue Numbers

Catalogue numbers for Hercules
Catalogue number Size Status
G31927 In distribution
G51797 In distribution
G51798 In distribution
G48732 In distribution
G31928 In distribution
G51796 In distribution
G51799 In distribution
G31926 In distribution
G31925 In distribution
G51795 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Disposable Dilation Balloon Micro-Tech (Nanjing) Co., Ltd. 99
Reliant(TM) Multistage Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. 37
Quantum TTC Cook Incorporated 27
Savary Gilliard Cook Incorporated 26
SafeGuide® Diversatek Healthcare Inc 25
Eliminator ConMed Corporation 21
ABC Dilatation Balloon Catheter Micro-Tech (Nanjing) Co., Ltd. 21
Flex-Ez Over the Wire Balloon Dilator Hobbs Medical, Inc. 19
Flex-Ez Stylet Wire Balloon Dilator Hobbs Medical, Inc. 19
Elation 5™ Merit Medical Systems, Inc. 18
SafeGuide® Single Diversatek Healthcare Inc 16
Conmed CleanGuide Jiangsu Grit Medical Technology Co., Ltd. 16

Showing 12 of 40. All products under Dilator, Esophageal

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