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

Footswitch

Name: Footswitch
Brand: Footswitch

Footswitch Monopolar

Registry build 21.09.26

65manufacturers in China registered for this device type

2catalogue numbers in this listing

4510(k) clearances naming this product code

15recalls 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 Footswitch
Listed by	Apyx Medical Corporation, United States
FDA product code	GEI
Device type	Electrosurgical, Cutting & Coagulation & Accessories
Device class	Class 2
Regulation	21 CFR 878.4400
Establishment	Contract manufacturer, Specification developer, Manufacturer
Record published	2020-03-23
Record revised	2021-11-01 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Footswitch
Catalogue number	Size	Status
APYX-1253B		In distribution
APYX-1254B		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
K230586	2023-06-09
K230272	2023-04-27
K223262	2023-02-23
K221830	2022-10-11

Recalls

15 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
2021-02-01	Class II	Device Design	There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.	5270 units
2021-02-01	Class II	Device Design	There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.	3862 units
2021-02-01	Class II	Device Design	There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.	5894 units
2020-04-20	Class II	Under Investigation by firm	Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.	38,738	2022-09-13
2020-04-20	Class II	Under Investigation by firm	Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.	13,948	2022-09-13
2018-06-18	Class II	Nonconforming Material/Component	There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue.	1,176 total units	2019-04-08
2018-02-08	Class II	Nonconforming Material/Component	Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the han	12 units	2020-09-17
2018-02-08	Class II	Nonconforming Material/Component	Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the han	6906 units	2020-09-17
2018-02-08	Class II	Nonconforming Material/Component	Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the han	595 units	2020-09-17
2018-02-08	Class II	Nonconforming Material/Component	Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the han	1005 units	2020-09-17
2018-02-08	Class II	Nonconforming Material/Component	Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the han	5416 units	2020-09-17
2016-07-18	Class II	Nonconforming Material/Component	The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.	95	2016-12-14
2016-07-18	Class II	Nonconforming Material/Component	The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.	95	2016-12-14
2016-07-18	Class II	Nonconforming Material/Component	The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.	95	2016-12-14
2016-07-18	Class II	Nonconforming Material/Component	The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.	95	2016-12-14

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.