What is FDA product code GEI?

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).

General & Plastic Surgery › SurgicalElectrosurgical, Cutting & Coagulation & Accessories

Venapax

Name: Venapax
Brand: Venapax

The Saphena Medical OnePass Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for…

Registry build 21.09.26

The Saphena Medical OnePass Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extra peritoneall or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external tothe parietal pleura, including nerves, blood vessels, and other tissues of the chest wall.

65manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GEI
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42
Hangzhou Kangji Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	27
Modern Medical Equipment Manufacturing Ltd.	Heng Li, Dongguan	Guangdong	Contract manufacturer	26
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24
Hangzhou Endo Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	19
Hong Qiangxing (Shen Zhen) Electronics Limited	Shenzhen	Guangdong	Contract manufacturer	19
Shenzhen MED-Link Electronics Tech Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	18
Sanbor Medical Xiamen, Inc.	Xiamen	Fujian	Contract manufacturer	16
ATL Technology DG,Ltd.	Dongguan	Guangdong	Contract manufacturer	14
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13
Guangzhou Huada Biotechnology Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	9

Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories

Record

Regulatory record for Venapax
Listed by	Saphena Medical, Inc., United States
FDA product code	GEI
Device type	Electrosurgical, Cutting & Coagulation & Accessories
Device class	Class 2
Regulation	21 CFR 878.4400
510(k)	K140603
Record published	2024-06-06
Record revised	2026-02-09 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Handling environment temperature -31 to 62 °C; Storage environment humidity 25 to 90 % RH
Distribution end date	2025-04-29

Catalogue Numbers

Catalogue numbers for Venapax
Catalogue number	Size	Status
VPX4000		In distribution
VPX3000		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Surgical Direct	Surgical Direct, Inc.	5,729
Speedlock	National Advanced Endoscopy Devices, Inc.	5,212
Stingray Surgical Products	Stingray Surgical Products L.L.C.	4,647
Kirwan	Kirwan Surgical Products, LLC.	1,901
Millennium	Avalign Technologies, Inc.	1,779
DANmed	Dannoritzer Medizintechnik GmbH & Co. KG	1,590
Elmed	Elmed, Inc.	1,519
Symmetry Olsen	Aspen Surgical Products, Inc.	1,219
Guenter Bissinger Medizintechnik GmbH	Günter Bissinger Medizintechnik GmbH	1,117
Ambler Surgical	Ambler Surgical, LLC	756
V. Mueller	Steris Corporation	661
Aesculap	Aesculap AG	544

Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K140603	2014-07-31

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Venapax
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Zimmer, Inc.	510(k) number	2024-09-17	Class II	Component change control	A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178″ difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move further into the plastic sheath that runs the length	432 units

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.