Medeon

The AbClose - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture,…

Registry build 21.09.26

The AbClose – Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures, facilitating standard suture closure techniques. The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by fold the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site. The AbClose – Port Site Closure Device is intended to be used by clinicians through prescription use only.

8manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Zhejiang (4), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HCF
Manufacturer City Province Registered as Device types
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Hangzhou Kangji Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Hangzhou Endo Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Changzhou 3R Medical Device Technology Co., Ltd. Changzhou Jiangsu Manufacturer 16
Auckland Medical Technology (Sichuan) Co., Ltd. Luzhou Sichuan Manufacturer 3

Record

Regulatory record for Medeon
Listed by Medeon Biodesign, Inc., Taiwan
FDA product code HCF
Device type Instrument, Ligature Passing And Knot Tying
Device class Class 1
Regulation 21 CFR 878.4800
Record published 2017-01-16
Record revised 2021-04-07 (version 4)

Specifications

Specifications
MRI safety MR Safe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Storage Special storage condition: Keep Dry; Storage environment temperature 20 to 25 °C; Storage environment humidity 30 to 60 % RH
Packaging Carton of 12

Catalogue Numbers

Catalogue numbers for Medeon
Catalogue number Size Status
M12 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Boss Instruments Boss Instruments, Ltd. 360
Elmed Elmed, Inc. 99
MSI Precision Specialty Instruments MED Saver, Inc. 69
Millennium Avalign Technologies, Inc. 53
Castroviejo Needle Holder Sontec Instruments, Inc. 46
Elmed Incorporated Elmed, Inc. 38
Aesculap Aesculap AG 26
Barraquer Needle Holder Sontec Instruments, Inc. 23
Wexler Surgical, Inc. Wexler Surgical, Inc. 20
Gimmi Gimmi Gmbh 16
Marina Medical Marina Medical Instruments, Inc. 16
Weck Teleflex Medical LLC 12

Showing 12 of 156. All products under Instrument, Ligature Passing And Knot Tying

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