Mega Soft
Reusable Patient Return Electrode, Mega Soft Universal Dual Cord, For Patients weighing over 0.8lb (350g), SAMPLE, 91cm Long x 51cm Wide x 0.3cm Thick
65manufacturers in China registered for this device type
31catalogue numbers in this listing
32510(k) clearances naming this product code
31recalls 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.
| 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 | Megadyne Medical Products, Inc., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K021077 |
| Record published | 2016-12-11 |
| Record revised | 2026-05-14 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 15 to 95 % RH; Storage environment temperature 5 to 50 °C |
| Packaging | Case of 40, case of 100 |
| Distribution end date | 2021-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0845 | In distribution | |
| 0830 | In distribution | |
| 0835S | In distribution | |
| 0835 | In distribution | |
| M2K04 | In distribution | |
| 0848 | In distribution | |
| 0830S | In distribution | |
| M2K09 | In distribution | |
| 0840 | In distribution | |
| M2K01 | In distribution | |
| M2K05 | In distribution | |
| 0845S | In distribution | |
| 0846S | In distribution | |
| M2K03 | In distribution | |
| M2K07 | In distribution | |
| M2K02 | In distribution | |
| 0847 | In distribution | |
| 0840S | In distribution | |
| M2K06 | In distribution | |
| PKIT001 | In distribution | |
| M2K08 | In distribution | |
| 0846 | In distribution | |
| M2K-05 | Withdrawn | |
| M2K-04 | Withdrawn | |
| M2K-03 | Withdrawn | |
| M2K-08 | Withdrawn | |
| M2K-09 | Withdrawn | |
| M2K-01 | Withdrawn | |
| M2K-02 | Withdrawn | |
| M2K-06 | Withdrawn | |
| M2K-07 | Withdrawn |
Same 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
| Clearance | Decision date |
|---|---|
| K233644 | 2024-07-12 |
| K213696 | 2022-01-21 |
| K193145 | 2020-03-24 |
| K141587 | 2015-02-18 |
| K133726 | 2014-01-24 |
| K080741 | 2008-12-16 |
| K081791 | 2008-10-21 |
| K072559 | 2007-10-05 |
| K050579 | 2005-03-24 |
| K050102 | 2005-02-01 |
| K040699 | 2004-06-04 |
| K031285 | 2003-05-19 |
| K021077 | 2002-04-17 |
| K982826 | 1998-11-06 |
| K973346 | 1997-11-07 |
| K972273 | 1997-07-08 |
| K965054 | 1997-01-24 |
| K953479 | 1995-10-12 |
| K946237 | 1995-06-07 |
| K951035 | 1995-04-07 |
| K943055 | 1994-12-21 |
| K945898 | 1994-12-13 |
| K942489 | 1994-07-25 |
| K932102 | 1993-09-23 |
| K926306 | 1993-02-05 |
| K922002 | 1992-09-02 |
| K913473 | 1991-09-06 |
| K912597 | 1991-09-06 |
| K912337 | 1991-08-16 |
| K913281 | 1991-08-16 |
| K904808 | 1991-01-04 |
| K903006 | 1990-09-20 |
Recalls Naming This Product
15 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Megadyne Medical Products, Inc. | 510(k) number | 2024-06-17 | Class I | Unknown/Undetermined by firm | To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads. | 259 units |
| Megadyne Medical Products, Inc. | 510(k) number | 2024-06-17 | Class I | Unknown/Undetermined by firm | To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads. | 2584 units |
| Megadyne Medical Products, Inc. | 510(k) number | 2024-06-17 | Class I | Unknown/Undetermined by firm | To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads. | 1463 units |
| Megadyne Medical Products, Inc. | 510(k) number | 2024-05-08 | Class I | Device Design | Reports of patient burns. | 1270 |
| Megadyne Medical Products, Inc. | 510(k) number | 2023-12-08 | Class I | Under Investigation by firm | Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, | 9,587 ea |
| Megadyne Medical Products, Inc. | UDI-DI | 2023-12-08 | Class I | Under Investigation by firm | Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, | 3,572 |
| Megadyne Medical Products, Inc. | UDI-DI | 2023-12-08 | Class I | Under Investigation by firm | Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, | 2,312 |
| Megadyne Medical Products, Inc. | UDI-DI | 2023-12-08 | Class I | Under Investigation by firm | Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, | |
| Megadyne Medical Products, Inc. | 510(k) number | 2023-06-01 | Class I | Under Investigation by firm | Firm has received reports of patient burns in surgical procedures where device was used. | 21,100 units |
| Megadyne Medical Products, Inc. | 510(k) number | 2023-06-01 | Class I | Under Investigation by firm | Firm has received reports of patient burns in surgical procedures where device was used. | 21,100 units |
| Megadyne Medical Products, Inc. | 510(k) number | 2023-06-01 | Class I | Under Investigation by firm | Firm has received reports of patient burns in surgical procedures where device was used. | 21,100 units |
| Megadyne Medical Products, Inc. | 510(k) number | 2023-06-01 | Class I | Under Investigation by firm | Firm has received reports of patient burns in surgical procedures where device was used. | 21,100 units |
| Megadyne Medical Products, Inc. | 510(k) number | 2023-06-01 | Class I | Under Investigation by firm | Firm has received reports of patient burns in surgical procedures where device was used. | 21,100 units |
| Megadyne Medical Products, Inc. | 510(k) number | 2023-06-01 | Class I | Under Investigation by firm | Firm has received reports of patient burns in surgical procedures where device was used. | 21,100 units |
| Megadyne Medical Products, Inc. | 510(k) number | 2023-06-01 | Class I | Under Investigation by firm | Firm has received reports of patient burns in surgical procedures where device was used. | 21,100 units |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-06-15 | Class II | Under Investigation by firm | An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU). | 241,457 units | |
| 2023-06-01 | Class I | Under Investigation by firm | Firm has received reports of patient burns in surgical procedures where device was used. | 21,100 units | |
| 2018-05-15 | Class II | Use error | If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient. | 8380 units | 2024-01-30 |
| 2014-02-27 | Class II | Use error | Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-ac | 494 | 2014-07-09 |
| 2013-08-07 | Class II | Process control | Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation. | 1816 | 2014-01-28 |
| 2009-10-13 | Not classified | Error in labeling | Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07. | 324 units | 2010-02-17 |
| 2006-04-06 | Not classified | Other | Surgical device packaging may be damaged and may compromise sterility. | 92 units | 2006-08-03 |
| 2006-04-06 | Not classified | Other | Surgical device packaging may be damaged and may compromise sterility. | 7,523 units | 2006-08-03 |
| 2006-04-06 | Not classified | Other | Surgical device packaging may be damaged and may compromise sterility. | 13,621 units | 2006-08-03 |
| 2006-04-06 | Not classified | Other | Surgical device packaging may be damaged and may compromise sterility. | 34,132 units | 2006-08-03 |
| 2006-04-06 | Not classified | Other | Surgical device packaging may be damaged and may compromise sterility. | 3,399 units | 2006-08-03 |
| 2006-04-06 | Not classified | Other | Surgical device packaging may be damaged and may compromise sterility. | 17,768 units | 2006-08-03 |
| 2006-04-06 | Not classified | Other | Surgical device packaging may be damaged and may compromise sterility. | 63,163 units | 2006-08-03 |
| 2006-04-06 | Not classified | Other | Surgical device packaging may be damaged and may compromise sterility. | 3,500 units | 2006-08-03 |
| 2002-12-20 | Not classified | Other | The metal substrate cautery tip may break during use. | 4855 | 2003-09-05 |
| 2002-12-20 | Not classified | Other | The metal substrate cautery tip may break during use. | 19464 | 2003-09-05 |
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.