Retention Device, Suture

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are based in Shanghai and Zhejiang: 3 hold an FDA registration.

MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Zhejiang Mediunion Healthcare Group Co., Ltd. Zhejiang, contract manufacturer
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

What Is FDA Product Code KGS?

Retention Device, Suture is FDA product code KGS, Class 1, 21 CFR 878.4930.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2006. None was by a company in China. The root cause the FDA records most often is Device Design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Retention Device, Suture

Bolsters

Surgical Rubber Tubing

Retention Device, Suture

Sveltefelt™ Quick Pledge™

Sveltefelt™ Quick Pledge™ Unit

Retention Device, Suture

Suturegard(R) Classic Adhesive Suture Retention Device

Suturegard(R) Classic Adhesive Suture Retention Device: 1 catalogue number listed by Suturegard Medical, Inc., United States, under Retention Device, Suture. 3 manufacturers in China are registered for this product code.

Retention Device, Suture

V-Close

The device is designed to be placed temporarily over a skin incision to assist with holding suture tension prior to final closure.

Retention Device, Suture

Perchik Button™

Perchik Button™: 1 catalogue number listed by Merit Medical Systems, Inc., United States, under Retention Device, Suture. 3 manufacturers in China are registered for this product code.

Retention Device, Suture

Suturegard(R) Hammerhead(TM) Adhesive Suture Retention Device

Suturegard(R) Hammerhead(TM) Adhesive Suture Retention Device: 1 catalogue number listed by Suturegard Medical, Inc., United States, under Retention Device, Suture. 3 manufacturers in China are registered for this product code.

Retention Device, Suture

Poly Suture Button

2 catalogue numbers from 904219, listed by Biomet Sports Medicine, United States, under Retention Device, Suture. 3 manufacturers in China are registered for this product code.

Retention Device, Suture

Slip-Not®

2 catalogue numbers from 00884450014578, listed by Merit Medical Systems, Inc., United States, under Retention Device, Suture. 3 manufacturers in China are registered for this product code.

Retention Device, Suture

LockeT Suture Retention Device

LockeT is a safe and effective suture retention device that is used in conjunction with a figure-of-eight suture to achieve hemostasis after access.

Retention Device, Suture

Retention Guard Suture Retention Plates – 3″

Catalogue number RG-3, listed by Preservation Solutions, Inc., United States, under Retention Device, Suture. 3 manufacturers in China are registered for this product code.

Retention Device, Suture

FlowStasis Single-Pack

Catalogue number 70-103, listed by Inari Medical, Inc., United States, under Retention Device, Suture. 3 manufacturers in China are registered for this product code.

Retention Device, Suture

Medline

AR-1291S Nitinol Suturing Ndl,w/Wire L

Retention Device, Suture

Suturegard Intraoperative Skin Relaxation Device

Suturegard Intraoperative Skin Relaxation Device: 1 catalogue number listed by Suturegard Medical, Inc., United States, under Retention Device, Suture. 3 manufacturers in China are registered for this product code.

Retention Device, Suture

StarGuard Suture Retention Plates – 7″

Catalogue number SG-7, listed by Preservation Solutions, Inc., United States, under Retention Device, Suture. 3 manufacturers in China are registered for this product code.

Retention Device, Suture

Medline Industries, Inc.

Rapid Deployment 10FR 6PK

Retention Device, Suture

Q-Stop

The device is designed to be placed temporarily over a skin incision to assist with holding suture tension prior to final closure.

Retention Device, Suture

Hewson Ligament Button

Hewson Ligament Button 19MM DIA

Retention Device, Suture

Retention Device, Suture

TI Button Plate 7 Holes

Retention Device, Suture

Hemigard Adhesive Suture Retention Device

Hemigard Adhesive Suture Retention Device: 1 catalogue number listed by Suturegard Medical, Inc., United States, under Retention Device, Suture. 3 manufacturers in China are registered for this product code.

Retention Device, Suture

Stent Buttons

2 catalogue numbers from 323011, listed by Boston Medical Products, Inc., United States, under Retention Device, Suture. 3 manufacturers in China are registered for this product code.

Retention Device, Suture

FlowStasis

Flowstatsis Suture Retention Device, 3-count

Retention Device, Suture

Perchik

Perchik Button

Retention Device, Suture

Ethicon

Retention Suture Bridge

Retention Device, Suture

Xtendobutton

XTENDOBUTTON Oval Medium 11 mm x 18 mm 7.5 mm peg

Retention Device, Suture

Vive

Pre-Wrap Tape (Black) 4PK

Retention Device, Suture

Medline Renewal

71111579 @hewson SUT Retriever (Black)

Retention Device, Suture

Bioseal Inc.

Button Polyester 9/16" - 14mm

Retention Device, Suture

StarGuard Suture Retention Plates – 9″

Catalogue number SG-9, listed by Preservation Solutions, Inc., United States, under Retention Device, Suture. 3 manufacturers in China are registered for this product code.

Retention Device, Suture

Retention Device, Suture

Fixation Button 17MM (BOX 6)

Retention Device, Suture

Dynamic Tissue Systems™

ABRA® Abdominal Wall Closure Set Extension

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