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).

Symmetry Surgical · Electrosurgical, Cutting & Coagulation & Accessories → General & Plastic Surgery

Name: Symmetry Surgical
Brand: Symmetry Surgical

65manufacturers in China registered for this device type

226catalogue 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 Symmetry Surgical
Listed by	Aspen Surgical Products, Inc., 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, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K940552
Record published	2016-09-22
Record revised	2026-07-01 (version 8)

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, manufacturing date
Sizes	Width 0.25 to 10 mm; length 3.5 to 17.75 in; length 10 to 450 mm; length 32 to 45 cm; needle gauge 15 to 22 G; shaft length 5 mm; angle 30 to 90 °; length 10 ft
Distribution end date	2025-04-25
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Symmetry Surgical
Catalogue number	Size	Status
90-2047		In distribution
97-1025RC	Length 370 mm	In distribution
97-3017RC	Length 9.4375 in	In distribution
90-5030	5 mm Diameter	In distribution
90-1030B	Width 5 mm	In distribution
90-9525L	Length 17.75 in	In distribution
97-3022RC	Length 9.4375 in	In distribution
90-4010L	Length 450 mm	In distribution
97-1008RC	Width 5 mm	In distribution
08-0059	Width 0.5 mm	In distribution
90-4012	Length 12.5 in	In distribution
90-1040I	5 mm Diameter	In distribution
90-1030IL	Length 450 mm	In distribution
90-4015	Length 13 in	In distribution
90-9527L	Length 450 mm	In distribution
08-0052	Width 0.4 mm	In distribution
90-1071	Length 350 mm	In distribution
90-2010L		In distribution
90-2011	Length 35 cm	In distribution
90-5053L	Length 17.75 in	In distribution
90-9523L	Length 17.75 in	In distribution
90-1008L	Length 450 mm	In distribution
90-2020	5 mm Diameter	In distribution
08-0203	Width 0.6 mm	In distribution
90-1005	Length 32 cm	In distribution
90-2005	Width 5 mm	In distribution
90-2020L	Length 17.75 in	In distribution
90-4012L	Length 17.75 in	In distribution
97-1033RC	Length 320 mm	In distribution
90-9527	Length 12.625 in	In distribution
90-9523	Length 12.625 in	In distribution
90-4005	Length 12.5 in	In distribution
97-1051DA-RC	Length 370 mm	In distribution
90-5052	5.0 mm Diameter	In distribution
50-2111	Length 10 ft	In distribution
97-1051RC	Length 37 cm	In distribution
90-4010	Length 12.5 in	In distribution
91-5035		In distribution
90-2010	Length 13.75 in	In distribution
97-1055RC	Length 320 mm	In distribution
90-1042IL	Length 450 mm	In distribution
90-5070L	Length 450 mm	In distribution
90-1035I	Length 320 mm	In distribution
90-1070	Length 32 cm	In distribution
90-1044	Length 12.5 in	In distribution
08-0053	Width 0.4 mm	In distribution
97-1029RC	Width 5 mm	In distribution
08-0048	Width 0.4 mm	In distribution
90-3039L	Length 450 mm	In distribution
90-1035L	Length 420 mm	In distribution
90-1072	Length 320 mm	In distribution
90-1074	Width 5 mm	In distribution
97-1056RC	Length 370 mm	In distribution
97-1056DA-RC	Length 370 mm	In distribution
90-5051	Length 13 in	In distribution
90-1035	Length 350 mm	In distribution
90-5048	Length 320 mm	In distribution
97-1042RC	Length 13.75 in	In distribution
08-0204	Width 0.6 mm	In distribution
90-5035	Length 10 mm	In distribution
90-6080	Width 5 mm	In distribution
08-1130		In distribution
90-9525	Length 12.625 in	In distribution
08-0057	Width 0.4 mm	In distribution
90-1040	Length 320 mm	In distribution
90-3038L	Length 450 mm	In distribution
90-5605	5.0 mm Diameter	In distribution
90-2015	Width 5 mm	In distribution
90-1007	Length 320 mm	In distribution
90-1008	Length 350 mm	In distribution
97-1093RC	Length 365 mm	In distribution
08-0020IG	Length 8.75 in	In distribution
90-5050	Length 13 in	In distribution
90-2011L	Length 45 cm	In distribution
08-0151	Width 0.25 mm	In distribution
08-0008	Width 0.5 mm	In distribution
90-1030	Length 35 cm	In distribution
90-1075L	Width 5 mm	In distribution
90-1071L	Width 5 mm	In distribution
90-1015	Length 32 cm	In distribution
90-5049	Length 320 mm	In distribution
97-3023RC	Length 240 mm	In distribution
90-2008	Length 35 cm	In distribution
90-1033	Length 320 mm	In distribution
90-9522L	Length 17.75 in	In distribution
08-0054	Width 0.4 mm	In distribution
08-0062NS	Length 8.75 in	In distribution
97-3004RC	Length 240 mm	In distribution
97-1030RC	Length 36 cm	In distribution
90-5051L	Length 17.75 in	In distribution
90-1009-H	Length 320 mm	In distribution
90-9526	Length 13 in	In distribution
90-5050L	Length 45 cm	In distribution
08-0056	Width 0.4 mm	In distribution
90-3035	Width 5 mm	In distribution
97-1069RC	Width 5 mm	In distribution
97-1035RC	Length 350 mm	In distribution
90-6081	Length 10 mm	In distribution
97-1030RCL	Length 450 mm	In distribution
08-0020I	Width 1 mm	In distribution
90-5053	Length 12.625 in	In distribution
90-9522	Length 13 in	In distribution
90-1031		In distribution
90-2020BL		Withdrawn
45-5397		Withdrawn
24-5127		Withdrawn
45-5107		Withdrawn
24-5300		Withdrawn
24-5303		Withdrawn
08-0072	Length 8.75 in	Withdrawn
32-5301		Withdrawn
24-5205		Withdrawn
32-5397		Withdrawn
97-1056DA-RCL		Withdrawn
90-1117L		Withdrawn
45-5202		Withdrawn
12-5380		Withdrawn
90-1068IL		Withdrawn
32-5302		Withdrawn
90-1116L		Withdrawn
08-0099I		Withdrawn
32-5127		Withdrawn
38-5397		Withdrawn
08-0055		Withdrawn
12-5381		Withdrawn
90-1015S		Withdrawn
90-2019		Withdrawn
38-5200		Withdrawn
38-5301		Withdrawn
90-1015B		Withdrawn
24-5117		Withdrawn
45-5105		Withdrawn
24-5108		Withdrawn
97-1042RCL		Withdrawn
90-9526L		Withdrawn
97-1083RCL		Withdrawn
97-1040RC		Withdrawn
38-5203		Withdrawn
24-1206		Withdrawn
90-1076		Withdrawn
90-1110L		Withdrawn
24-5107		Withdrawn
90-1035BL		Withdrawn
38-5107		Withdrawn
38-5303		Withdrawn
38-5127		Withdrawn
45-5399	Length 45 mm	Withdrawn
90-9522-H		Withdrawn
38-5101		Withdrawn
32-5102		Withdrawn
90-2010I		Withdrawn
24-5207		Withdrawn
12-5382		Withdrawn
45-5108		Withdrawn
38-5106		Withdrawn
90-1068B		Withdrawn
12-5390		Withdrawn
38-5108		Withdrawn
24-5106		Withdrawn
45-5205		Withdrawn
32-5100		Withdrawn
38-5300		Withdrawn
32-5303		Withdrawn
38-5202		Withdrawn
90-1015L		Withdrawn
08-0095		Withdrawn
90-1073		Withdrawn
45-5304		Withdrawn
90-1073LS		Withdrawn
38-5204		Withdrawn
97-1026RC		Withdrawn
24-5100		Withdrawn
45-5200		Withdrawn
38-5102		Withdrawn
24-5301		Withdrawn
90-1050L		Withdrawn
38-5117		Withdrawn
90-2010B		Withdrawn
45-5301		Withdrawn
455100R		Withdrawn
32-5201		Withdrawn
24-5101		Withdrawn
90-2003BL		Withdrawn
45-5207		Withdrawn
32-5107		Withdrawn
38-5105		Withdrawn
90-1075		Withdrawn
08-0071		Withdrawn
90-1069		Withdrawn
45-5203		Withdrawn
38-1206		Withdrawn
32-5101		Withdrawn
45-5201		Withdrawn
38-5201		Withdrawn
32-5105		Withdrawn
45-5101		Withdrawn
32-5202		Withdrawn
38-5205		Withdrawn
90-1009L		Withdrawn
90-2003IL		Withdrawn
90-2003B		Withdrawn
32-5207		Withdrawn
45-5100		Withdrawn
45-5303		Withdrawn
08-0400		Withdrawn
32-5300		Withdrawn
38-5302		Withdrawn
45-5117		Withdrawn
32-5205		Withdrawn
32-5203		Withdrawn
97-1028RC		Withdrawn
32-5108		Withdrawn
90-1071M		Withdrawn
97-1009RC		Withdrawn
32-5204		Withdrawn
38-5207		Withdrawn
38-5100		Withdrawn
90-1035RL	Width 5 mm	Withdrawn
24-5102		Withdrawn
24-5105		Withdrawn
32-5200		Withdrawn
45-5106		Withdrawn
38-5304		Withdrawn
32-5106		Withdrawn
32-5117		Withdrawn
45-5102R		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
K030339	2003-03-07

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 Symmetry Surgical
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Olsen Medical	510(k) number	2018-05-11	Class II	Package design/selection	Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.	323,886 devices	2019-04-15
Olsen Medical	510(k) number	2018-05-11	Class II	Package design/selection	Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.	71,890 devices	2019-04-15

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.

Symmetry Surgical