PlaDuo System
510(k) K232223
PlaDuo System is a medical device (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by shenb Co., Ltd., cleared under FDA 510(k) K232223 on 24 Oct 2023, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232223 | Date24 Oct 2023 | StatusActive |
Official records
- FDA 510(k) database K232223
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEI
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K232223
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| PlaDuo PRO System | PlaDuo PRO System | 08800017101422 | — | On the market |
| PlaDuo System | PlaDuo | 08800017101118 | — | On the market |
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