CellFX System
by Pulse Biosciences, Inc 4 variants
510(k) K213674
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) K213674 on 22 Sep 2022, 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 | NumberK213674 | Date22 Sep 2022 | StatusActive |
Official records
- FDA 510(k) database K213674
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- Withdrawn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).
- REPROCESSED SURGICAL SCISSORS AND GRASPERS by Clearmedical, Inc.
- Olympus WA22542S by Olympus Winter & Ibe GmbH
- MicroFrance Monopolar and Bipolar Electrosurgical Instruments by Integra Microfrance
- MEGA POWER ELECTROSURGICAL GENERATOR by Megadyne Medical Products, Inc.
- POTENZA Tip S-25 by Jeisys Medical Incorporated
- Integra® MicroFrance® CEV8612D by Integra Microfrance
- ELECTRODE, BOVIE DISPERSIVE by Nixon, Hargrave, Devans
- Guenter Bissinger Medizintechnik GmbH 81618204 by Günter Bissinger Medizintechnik GmbH
- Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) by Modern Medical Equipment Manufacturing Limited
- SPIRIX(TM) by Medical/Surgical Specialties, Ltd.