What is FDA product code GCJ?

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Gastroenterology & Urology › DiagnosticLaparoscope, General & Plastic Surgery

2EZee Specimen Retrieval

Name: 2EZee Specimen Retrieval
Brand: 2EZee Specimen Retrieval

Catalogue number 550-000-200, listed by Genicon, Inc., United States, under Laparoscope, General & Plastic Surgery. 46 manufacturers in China are registered for this product code.

Registry build 21.09.26

46manufacturers in China registered for this device type

1catalogue number

6510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Concentrated in Guangdong (15), Jiangsu (13), Zhejiang (7). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GCJ
Manufacturer	City	Province	Registered as	Device types
Hangzhou Kangji Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	27
Modern Medical Equipment Manufacturing Ltd.	Heng Li, Dongguan	Guangdong	Contract manufacturer	26
Hangzhou Endo Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	19
Beilun Plastech Inc	Ningbo	Zhejiang	Contract manufacturer	13
Dongguan Honfield Precision Parts Co., Ltd.	Zhangmutou, Dongguan	Guangdong	Contract manufacturer	8
Qingdao O-MEC Medical Technology Co., Ltd.	Qingdao	Shandong	Contract manufacturer	6
Shenzhen Jingxintai Houseware Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	6
MediConcepts Technology (Shenzhen) Company Limited	Shenzhen	Guangdong	Contract manufacturer	5
Qisda Electronics (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	5
Barco (Suzhou) Healthcare Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	4
Jiangsu Bana Medical Technology Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	4
Comhuge Medical Wire AND Harness Technology Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	2

Showing 12 of 46. All 46 manufacturers in China registered for Laparoscope, General & Plastic Surgery

Record

Regulatory record for 2EZee Specimen Retrieval
Listed by	Genicon, Inc., United States
FDA product code	GCJ
Device type	Laparoscope, General & Plastic Surgery
Device class	Class 2
Regulation	21 CFR 876.1500
Record published	2018-08-15

Specifications

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

Catalogue Numbers

Catalogue numbers for 2EZee Specimen Retrieval
Catalogue number	Size	Status
550-000-200		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Elmed	Elmed, Inc.	3,796
Surgical Direct	Surgical Direct, Inc.	2,319
Novo Surgical	Novo Surgical, Inc.	1,320
Elmed Incorporated	Elmed, Inc.	911
Laparoscope, General & Plastic Surgery	Karl Storz GmbH & Co. KG	774
Snowden-Pencer	Steris Corporation	693
Millennium	Avalign Technologies, Inc.	683
Hermann Medizintechnik GmbH	Hermann Medizintechnik Gmbh	615
Clickline	Karl Storz GmbH & Co. KG	582
V. Mueller	Carefusion 2200, Inc.	553
Grasping forceps	Sopro-Comeg GmbH	462
Gimmi	Gimmi Gmbh	387

Showing 12 of 1,584. All products under Laparoscope, General & Plastic Surgery

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K181791	2018-08-21
K180836	2018-04-18
K180579	2018-03-19
K162059	2016-09-29
K132375	2014-06-12
K041967	2004-11-12

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2018-06-27	Class II	Labeling design	Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.	1550
2017-07-19	Class II	Device Design	Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.	2,967 units	2020-05-18

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.