Who else makes this device?

Name: Ethicon
Brand: Ethicon

Ethicon · Retention Device, Suture → General & Plastic Surgery

3manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (2), Zhejiang (1).

Chinese manufacturers registered for FDA product code KGS
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Zhejiang Mediunion Healthcare Group Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	105
MicroPort Orthopedics Global Supply Center Limited	Shanghai	Shanghai	Contract manufacturer	82

Record

Regulatory record for Ethicon
Listed by	Ethicon, Inc., United States
FDA product code	KGS
Device type	Retention Device, Suture
Device class	Class 1
Regulation	21 CFR 878.4930
Establishment	Contract manufacturer, Specification developer, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2015-09-01
Record revised	2022-07-21 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date
Packaging	Box of 12
Distribution end date	2022-07-20

Catalogue Numbers

Catalogue numbers for Ethicon
Catalogue number	Size	Status
450G		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bioseal Inc.	Bioseal	20
Xtendobutton	Smith & Nephew, Inc.	7
Dynamic Tissue Systems™	Southmedic, Inc.	4
Retention Device, Suture	Smith & Nephew, Inc.	2
Vive	Vive Health LLC	2
Perchik	AngioDynamics, Inc.	2
FlowStasis	Inari Medical, Inc.	2
Stent Buttons	Boston Medical Products, Inc.	2
Medline Industries, Inc.	Medline Industries, Inc.	2
Medline	Medline Industries, Inc.	2
Slip-Not®	Merit Medical Systems, Inc.	2
Poly Suture Button	Biomet Sports Medicine	2

Showing 12 of 29. All products under Retention Device, Suture

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K832138	1984-05-23
K812819	1981-11-20

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.

Ethicon