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

Bladeless Laparoscopic Access Port

Name: Bladeless Laparoscopic Access Port
Brand: Bladeless Laparoscopic Access Port

Catalogue number AVM-900, listed by Coopersurgical, 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

1recall

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 Bladeless Laparoscopic Access Port
Listed by	Coopersurgical, Inc., United States
FDA product code	GCJ
Device type	Laparoscope, General & Plastic Surgery
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K010007
Record published	2016-09-26
Record revised	2024-02-28 (version 6)

Specifications

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

Catalogue Numbers

Catalogue numbers for Bladeless Laparoscopic Access Port
Catalogue number	Size	Status
AVM-900		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

Recalls Naming This Product

3 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Bladeless Laparoscopic Access Port
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Teleflex Medical LLC	510(k) number	2014-03-11	Class II	Nonconforming Material/Component	Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.	55,521 ea. in total	2017-08-15
Teleflex Medical LLC	510(k) number	2014-03-11	Class II	Nonconforming Material/Component	Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.	55,521 ea. in total	2017-08-15
Teleflex Medical LLC	510(k) number	2014-03-11	Class II	Nonconforming Material/Component	Complaints of leakage of insufflation gas through the device.	55,521 total	2016-01-28

Recalls

1 of these is 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
2023-08-29	Class II	Labeling Change Control	Incorrect component descriptions within the “Contents” section on the Tyvek lid for individual kit trays.	127 boxes, 3 kits per box (381 kits total)

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.