Surgical Direct
5mm Hunter Bowel Grasper, Fenestrated, 20.9mm Jaw Length; Single Piece; Non-Locking, Insulated, Stainless Steel Handle, Non-Rotating with HF Post; Bariatric Length
65manufacturers in China registered for this device type
5,729catalogue 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.
| 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
| Listed by | Surgical Direct, Inc., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Repacker / relabeller |
| 510(k) | K914910 |
| Record published | 2023-10-05 |
| Record revised | 2024-04-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Length 32 to 48 cm; outer diameter 2 to 10 mm; catheter gauge 5 to 7 Fr; length 3.5 to 9 in; length 10 ft |
| Distribution end date | 2025-03-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD01088-32010-3 | In distribution | |
| SD81048-11005-4 | In distribution | |
| SD03088-11001-3 | In distribution | |
| SD25108-31001-4 | In distribution | |
| SD40068-11010-4 | In distribution | |
| SD88171 | In distribution | |
| SD60108-31005-3 | In distribution | |
| SD88326 | In distribution | |
| SD44062-31005-1 | In distribution | |
| SD04068-32020-1 | In distribution | |
| SD43098-11020-4 | In distribution | |
| SD42078-31001-1 | In distribution | |
| SD03088-31001-3 | In distribution | |
| SD22068-31020-3 | In distribution | |
| SD40068-31010-4 | In distribution | |
| SD20108-12015-3 | In distribution | |
| SD05068-11005-2 | In distribution | |
| SD01128-12001-1 | In distribution | |
| SD43098-32001-3 | In distribution | |
| SD01066-11001-1A | In distribution | |
| SD20108-12010-3 | In distribution | |
| SD01108-32001-3 | In distribution | |
| SD20108-11020-4 | In distribution | |
| SD98111 | Length 33 cm | In distribution |
| SD43088-31010-4 | In distribution | |
| SD5-48 | In distribution | |
| SD9814452 | Length 33 cm | In distribution |
| SD98104 | Length 33 cm | In distribution |
| SD04078-32001-2 | In distribution | |
| SD04078-12001-3 | In distribution | |
| SD880910 | In distribution | |
| SD8883825 | In distribution | |
| SD40048-12020-3 | In distribution | |
| SD40058-11001-4 | In distribution | |
| SD20078-12001-4 | In distribution | |
| SD88522 | In distribution | |
| SD20068-31005-3 | In distribution | |
| SD8470-08B | In distribution | |
| SD40068-32020-3 | In distribution | |
| SD8822437 | In distribution | |
| SD77105-200M | In distribution | |
| SD261769 | In distribution | |
| SD25080-11010-4 | In distribution | |
| SD23090-31001-4 | In distribution | |
| SD60108-11005-1 | In distribution | |
| SD04108-31001-1 | In distribution | |
| SD20108-11015-1 | In distribution | |
| SD01058-12010-1 | In distribution | |
| SD40108-11010-3 | In distribution | |
| SD25090-31020-1 | In distribution | |
| SD80056-11010-2 | In distribution | |
| SD01108-31005-3 | In distribution | |
| SD8410-123 | In distribution | |
| SD110500002 | In distribution | |
| SD20078-32020-3 | In distribution | |
| SD20088-31001-4 | In distribution | |
| SD44062-11005-4 | In distribution | |
| SD894632 | In distribution | |
| SD01128-31020-4 | In distribution | |
| SD24088-31010-1 | In distribution | |
| SD01078-31010-2 | In distribution | |
| SD396104 | In distribution | |
| SD02078-11001-4 | In distribution | |
| SD05068-12001-2 | In distribution | |
| SD42068-11005-4 | In distribution | |
| SD9800454 | In distribution | |
| SD5-46 | In distribution | |
| SD05068-31020-2 | In distribution | |
| SD01078-11005-4 | In distribution | |
| SD40068-11015-1 | In distribution | |
| SD898945 | In distribution | |
| SD44068-12020-1 | In distribution | |
| SD90269110 | In distribution | |
| SD05098-32010-1 | In distribution | |
| SD04068-11020-4 | In distribution | |
| SD22088-31010-2 | In distribution | |
| SD20068-32020-4 | In distribution | |
| SD25080-11015-4 | In distribution | |
| SD03098-31020-2 | In distribution | |
| SD40088-12020-3 | In distribution | |
| SD42068-11020-4 | In distribution | |
| SD04108-31005-3 | In distribution | |
| SD22088-31001-3 | In distribution | |
| SD04088-12005-2 | In distribution | |
| SD2151006 | In distribution | |
| SD43098-12020-2 | In distribution | |
| SD81048-32005-1 | In distribution | |
| SD62078-11007-1 | In distribution | |
| SD88295A | In distribution | |
| SD40078-31005-1 | In distribution | |
| SD05088-11015-4 | In distribution | |
| SD01108-32020-1 | In distribution | |
| SD110500006 | In distribution | |
| SD40128-32010-2 | In distribution | |
| SD550-14 | In distribution | |
| SD43088-31020-3 | In distribution | |
| SD40088-31005-3 | In distribution | |
| SD22088-13015-3 | In distribution | |
| SD43078-31001-4 | In distribution | |
| SD52-26 | In distribution | |
| SD44068-31010-3 | In distribution | |
| SD60088-31020-2 | In distribution | |
| SD01108-32010-4 | In distribution | |
| SD13537010C | In distribution | |
| SD42098-11005-2 | In distribution | |
| SD07080-11001-2 | In distribution | |
| SD8907 | In distribution | |
| SD01058-11005-4 | In distribution | |
| SD88833245 | In distribution | |
| SD8212-043 | In distribution | |
| SD24088-31015-2 | In distribution | |
| SD22108-13010-1 | In distribution | |
| SD07100-11015-3 | In distribution | |
| SD23098-31015-3 | In distribution | |
| SD43078-12015-4 | In distribution | |
| SD43078-31001-2 | In distribution | |
| SD60088-31001-2 | In distribution | |
| SD84042-32005-1 | In distribution | |
| SD43088-11010-4 | In distribution | |
| SD98012 | Length 33 cm | In distribution |
| SD01128-31015-1 | In distribution | |
| SD01078-12001-2 | In distribution | |
| SD40128-11001-4 | In distribution | |
| SD42078-11010-1 | In distribution | |
| SD06078-11020-1 | In distribution | |
| SD60078-31005-1 | In distribution | |
| SD42098-11020-1 | In distribution | |
| SD43088-11010-2 | In distribution | |
| SD110500401 | In distribution | |
| SD40058-12015-2 | In distribution | |
| SD01108-11020-2 | In distribution | |
| SD05088-31015-1 | In distribution | |
| SD43098-31010-4 | In distribution | |
| SD88719 | In distribution | |
| SD906 | In distribution | |
| SD475200-103SS | In distribution | |
| SD01088-32015-2 | In distribution | |
| SD02078-31015-4 | In distribution | |
| SD84042-31005-4 | In distribution | |
| SD8977 | In distribution | |
| SD02068-11020-2 | In distribution | |
| SD04078-11001-2 | In distribution | |
| SD43088-32001-1 | In distribution | |
| SD43098-12020-1 | In distribution | |
| SD82058-12001-3 | In distribution | |
| SD05068-12015-2 | In distribution | |
| SD40078-11015-4 | In distribution | |
| SD61068-31003-2 | In distribution | |
| SD23098-31010-4 | In distribution | |
| SD05098-12010-3 | In distribution | |
| SD23098-11020-3 | In distribution | |
| SD43088-31020-2 | In distribution | |
| SD05098-12005-1 | In distribution | |
| SD20108-31015-1 | In distribution | |
| SD60108-31015-3 | In distribution | |
| SD8959-903 | In distribution | |
| SD05078-11020-4 | In distribution | |
| SD41068-11015-1 | In distribution | |
| SD912 | In distribution | |
| S8350.01 | In distribution | |
| SD84042-31005-2 | In distribution | |
| SD22108-14001-3 | In distribution | |
| SD04068-32005-1 | In distribution | |
| SD22068-11015-2 | In distribution | |
| SD930 | In distribution | |
| SD43098-32010-1 | In distribution | |
| SD43098-31020-2 | In distribution | |
| SD24078-31010-2 | In distribution | |
| SD43078-11001-3 | In distribution | |
| SD9811451 | Length 45 cm | In distribution |
| SD40088-32015-4 | In distribution | |
| SD07090-11015-1 | In distribution | |
| SD04068-11001-1 | In distribution | |
| SD25108-11020-3 | In distribution | |
| SD883045102 | In distribution | |
| SD9813453 | Length 45 cm | In distribution |
| SD01078-12005-4 | In distribution | |
| SD8936-904 | In distribution | |
| SD20108-32001-1 | In distribution | |
| SD83048-11005-4 | In distribution | |
| SD05068-11015-4 | In distribution | |
| SD135207C | In distribution | |
| SD135310C | In distribution | |
| SD42068-11020-3 | In distribution | |
| SD40048-11020-1 | In distribution | |
| SD60108-11010-4 | In distribution | |
| SD20068-12010-3 | In distribution | |
| SD22108-33020-2 | In distribution | |
| SD61078-31007-2 | In distribution | |
| SD05078-12015-1 | In distribution | |
| SD24068-11015-2 | In distribution | |
| SD41078-11015-2 | In distribution | |
| SD42068-11005-3 | In distribution | |
| SD07070-11005-2 | In distribution | |
| SD40048-11001-4 | In distribution | |
| SD24068-31010-3 | In distribution | |
| SD22108-14015-1 | In distribution | |
| SD7927-08 | In distribution | |
| SD22108-11210-1 | In distribution | |
| SD44068-32005-4 | In distribution | |
| SD25070-11005-3 | In distribution | |
| SD40128-31005-4 | In distribution | |
| SD22108-34015-3 | In distribution | |
| SD04108-11005-2 | In distribution | |
| SD43078-31010-1 | In distribution | |
| SD5-39 | In distribution | |
| SD04108-12020-3 | In distribution | |
| SD40108-11020-4 | In distribution | |
| SD25090-11005-1 | In distribution | |
| SD25108-31010-3 | In distribution | |
| SD01128-31005-3 | In distribution | |
| SD07090-11005-2 | In distribution | |
| SD88225A | In distribution | |
| SD40068-12010-1 | In distribution | |
| SD01068-12015-1 | In distribution | |
| SD43088-31005-1 | In distribution | |
| SD8997 | In distribution | |
| SD62078-11007-3 | In distribution | |
| SD80056-31010-1 | In distribution | |
| SD926 | In distribution | |
| SD01058-11015-3 | In distribution | |
| SD23098-11010-2 | In distribution | |
| SD41078-31020-1 | In distribution | |
| SD42068-31010-2 | In distribution | |
| SD88191 | In distribution | |
| SD04078-11020-3 | In distribution | |
| SD07080-11005-1 | In distribution | |
| SD23090-31020-3 | In distribution | |
| SD20078-11015-4 | In distribution | |
| SD40078-12015-2 | In distribution | |
| SD62090-11007-4 | In distribution | |
| SD01128-31005-4 | In distribution | |
| SD8823437 | In distribution | |
| SD40088-31001-2 | In distribution | |
| SD02078-31020-4 | In distribution | |
| SD07070-31015-3 | In distribution | |
| SD8940 | In distribution | |
| SD06068-11015-1 | In distribution | |
| SD37-300 | In distribution | |
| SD40078-31020-4 | In distribution | |
| SD41078-11005-2 | In distribution | |
| SD98354 | In distribution | |
| SD04108-31020-1 | In distribution | |
| SD01108-32001-4 | In distribution | |
| SD881010 | In distribution | |
| SD20088-32015-4 | In distribution | |
| SD894345 | In distribution | |
| SD8450-12 | In distribution | |
| SD77132-01 | In distribution | |
| SD8834245 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Novo Surgical | Novo Surgical, Inc. | 510 |
Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193018 | 2019-12-20 |
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Silex Medical, LLC | 510(k) number | 2024-01-09 | Class II | Process control | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. | 2 units |
| Silex Medical, LLC | 510(k) number | 2024-01-09 | Class II | Process control | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. | 10 units |
| Silex Medical, LLC | 510(k) number | 2024-01-09 | Class II | Process control | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. | 8 units |
| Silex Medical, LLC | 510(k) number | 2024-01-09 | Class II | Process control | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. | 29 units |
| Silex Medical, LLC | 510(k) number | 2024-01-09 | Class II | Process control | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. | 6 units |
| Silex Medical, LLC | 510(k) number | 2024-01-09 | Class II | Process control | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. | 7 units |
| Silex Medical, LLC | 510(k) number | 2024-01-09 | Class II | Process control | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. | 105 units |
| Silex Medical, LLC | 510(k) number | 2024-01-09 | Class II | Process control | Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. | 2 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.