Mega Soft 0840S
by Megadyne Medical Products, Inc.
Mega Soft 0840S is a Class II device made by Megadyne Medical Products, Inc., cleared under FDA 510(k) K080741 on 16 Dec 2008 and listed in FDA GUDID since 11 Dec 2016 (UDI-DI 10614559103159), active as of 23 Oct 2026. 3 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
3 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10614559103159 | Date11 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK080741 | Date16 Dec 2008 | StatusActive |
Official records
- AccessGUDID record 10614559103159
- FDA 510(k) database K080741
Across registries
- FDA 510(k) K080741 decided 16 Dec 2008 Active
- FDA GUDID UDI-DI 10614559103159 listed 11 Dec 2016 Listed
Recalls
-
- Ongoing Z-2248-2024
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.
-
- Ongoing Z-1920-2024
Reports of patient burns.
-
- Ongoing Z-1997-2023
Firm has received reports of patient burns in surgical procedures where device was used.
Timeline
- Cleared FDA 510(k) K080741
- Listed FDA GUDID 10614559103159
- Recall initiated FDA recalls Z-1997-2023
- Recall initiated FDA recalls Z-1920-2024
- Recall initiated FDA recalls Z-2248-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mega Soft
- Generic name
- Electrosurgical return electrode, reusable
- Model / Ref / Catalog
- 0840S
- Primary DI / UDI-DI
- 10614559103159
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical return electrode, reusable
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Electrosurgical return electrode, reusable.