CellFX FG5006-01, FG6009-01
CellFX FG5006-01, FG6009-01 (CTT0251) is an electrosurgical system (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Pulse Biosciences, Inc, cleared under FDA 510(k) K203299 on 2 Feb 2021 and listed in FDA GUDID since 8 Mar 2021 (UDI-DI 00850003231624), active as of 8 Nov 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 | Number00850003231624 | Date8 Mar 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203299 | Date2 Feb 2021 | StatusActive |
Official records
- AccessGUDID record 00850003231624
- FDA 510(k) database K203299
Across registries
- FDA 510(k) K203299 decided 2 Feb 2021 Active
- FDA GUDID UDI-DI 00850003231624 listed 8 Mar 2021 Listed
Timeline
- Cleared FDA 510(k) K203299
- Listed FDA GUDID 00850003231624
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CellFX
- Generic name
- Electrosurgical system
- Model / Ref / Catalog
- FG5006-01, FG6009-01, CTT0251
- Primary DI / UDI-DI
- 00850003231624
- 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
- Sterilisation method
- Ethylene Oxide
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