Cellinew
Cellinew is a Class II device made by VIOL Co., Ltd., cleared under FDA 510(k) K240897 on 26 Nov 2024 and listed in FDA GUDID since 9 Dec 2024 (UDI-DI 08809502330347), active as of 8 Jun 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 | Number08809502330347 | Date9 Dec 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK240897 | Date26 Nov 2024 | StatusActive |
Official records
- AccessGUDID record 08809502330347
- FDA 510(k) database K240897
Across registries
- FDA 510(k) K240897 decided 26 Nov 2024 Active
- FDA GUDID UDI-DI 08809502330347 listed 9 Dec 2024 Listed
Timeline
- Cleared FDA 510(k) K240897
- Listed FDA GUDID 08809502330347
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrosurgical system
- Model / reference
- CELLINEW
- Primary DI / UDI-DI
- 08809502330347
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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