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

Hemostatix Thermal Scalpel System Blade

Name: Hemostatix Thermal Scalpel System Blade
Brand: Hemostatix Thermal Scalpel System Blade

The filing maps reference 7013-5815 to a sterile disposable #15 scalpel blade for the Model P8400 controller. The system is designed to retain steel-scalpel cutting characteristics while…

Registry build 21.09.26

The filing maps reference 7013-5815 to a sterile disposable #15 scalpel blade for the Model P8400 controller.

The system is designed to retain steel-scalpel cutting characteristics while providing hemostasis as the surgeon incises.

Listed Item

Hemostatix Thermal Scalpel System Model 5815 Blade

Blade and System

The filing describes an adjustable-temperature blade and states that the sharp steel blade and scalpel pressure provide the incising action. The summary lists #10, #12, and #15 disposable blade options for the P8400 controller.

65manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

2recalls 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 Hemostatix Thermal Scalpel System Blade
Listed by	Hemostatix Medical Technologies, LLC, United States
FDA product code	GEI
Device type	Electrosurgical, Cutting & Coagulation & Accessories
Device class	Class 2
Regulation	21 CFR 878.4400
510(k)	K183009
Record published	2019-04-11

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

Catalogue Numbers

Catalogue numbers for Hemostatix Thermal Scalpel System Blade
Catalogue number	Size	Per pack	Status
7013-5815		24	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
K183009	2018-11-26
K091107	2009-05-01

Recalls

The FDA has not published a severity grade for these. 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
2010-07-27	Not classified	Other	Lack of sterility assurance	219 units	2010-11-29
2010-07-27	Not classified	Other	Lack of sterility assurance	40 units	2010-11-29

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.