L’disq® PD04
L’disq® PD04 is a Class II device made by CG MedTech Co., Ltd., cleared under FDA 510(k) K132797 on 30 Jul 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08800015911832), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08800015911832 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132797 | Date30 Jul 2014 | StatusActive |
Official records
- AccessGUDID record 08800015911832
- FDA 510(k) database K132797
Across registries
- FDA 510(k) K132797 decided 30 Jul 2014 Active
- FDA GUDID UDI-DI 08800015911832 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K132797
- Listed FDA GUDID 08800015911832
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- L’disq®
- Generic name
- Electrosurgical return electrode, single-use, sterile
- Model / reference
- PD04
- Primary DI / UDI-DI
- 08800015911832
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical return electrode, single-use, sterile
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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