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).

ParallelPort · Electrosurgical, Cutting & Coagulation & Accessories → General & Plastic Surgery

Name: ParallelPort
Brand: ParallelPort

65manufacturers in China registered for this device type

1catalogue number

9510(k) clearances naming this product code

4recalls on this code

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 ParallelPort
Listed by	Stryker GmbH, Switzerland
FDA product code	GEI
Device type	Electrosurgical, Cutting & Coagulation & Accessories
Device class	Class 2
Regulation	21 CFR 878.4400
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
510(k)	K935237
Record published	2016-09-23
Record revised	2023-04-04 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for ParallelPort
Catalogue number	Size	Status
0233032200		In distribution

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
K221074	2022-09-16
K171391	2018-01-26
K160050	2016-05-03
K160693	2016-04-13
K153679	2016-01-22
K063480	2007-05-22
K061225	2006-09-14
K033232	2004-02-25
K861742	1986-07-23

Recalls Naming This Product

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

Recalls naming the identifiers of ParallelPort
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Stryker Endoscopy	510(k) number	2014-04-16	Class II	Reprocessing Controls	Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.	2591 trays	2014-08-18
Stryker Endoscopy	510(k) number	2012-06-19	Class II	Process control	The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the “Instructions for Use”; due to the firm’s evaluation that identified original validation was not done at worst case conditions.	6388 units	2012-10-23

Recalls

4 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
2020-03-26	Class II	Under Investigation by firm	Due to a distribution error, product from the affected lot was shipped expired.	40 units	2020-07-15
2020-01-13	Class II	Under Investigation by firm	Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.	15150	2021-08-10
2020-01-13	Class II	Under Investigation by firm	Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.	15150	2021-08-10
2020-01-13	Class II	Under Investigation by firm	Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.	15150	2021-08-10

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.

ParallelPort