CellFX System
by Pulse Biosciences, Inc 4 variants
510(k) K211444
CellFX System is a medical device (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Pulse Biosciences, Inc, cleared under FDA 510(k) K211444 on 25 Aug 2021, 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 | FDA 510(k)SESE | NumberK211444 | Date25 Aug 2021 | StatusActive |
Official records
- FDA 510(k) database K211444
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEI
- FDA applicant
- Pulse Biosciences, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).
- Guenter Bissinger Medizintechnik GmbH 81615203 by Günter Bissinger Medizintechnik GmbH
- ERBE 20189-350 by Erbe Elektromedizin GmbH
- PlasmaJet Neutral Plasma Surgery System OS-CG-05-07 by Plasma Surgical, Ltd.
- BIPOLAR GRASPING FORCEPS BIQ+ by Olympus America, Inc.
- SPINAUT-P by IMEDICOM CO., LTD.
- ERBE 20193-074 by Erbe Elektromedizin GmbH
- ENTire IRE System by Entire Medical, Ltd.
- MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010 by Hysterx, Inc.
- UM-D3000/UM-D4000 by J.J. Consulting Services, Inc.
- Sutter 784977SGSZ by Sutter Medizintechnik GmbH