FDA.reportPublic FDA data

CellFX

Primary DI
00850003231419
Brand
CellFX
Company
Pulse Biosciences, Inc.
Model
FG2250-01
Catalog number
CH03
Device description
CellFX Handpiece
Published
2021-02-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203299000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203299000CellFX SystemPulse Biosciences, Inc.2021-02-02GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003231419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003231419008500032314198500032314190850003231419

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for argon-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080114073
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003231594CellFXFG5003-01CTT01512021-03-08
00850003231600CellFXFG5004-01CTT01522021-02-26
00850003231624CellFXFG5006-01, FG6009-01CTT02512021-03-08
00850003231631CellFXFG5007-01, FG6010-01CTT02522021-02-26
00850003231655CellFXFG5012-01, FG6015-01CTT05012021-03-08
00850003231662CellFXFG5013-01, FG6016-01CTT05022021-02-26
00850003231389CellFXFG2100-01CFX102021-02-26
10850003231591CellFXFG5003-01CTT01512021-03-08
10850003231621CellFXFG5006-01, FG6009-01CTT02512021-03-08
10850003231652CellFXFG5012-01, FG6015-01CTT05012021-03-08
10850003231607CellFXFG5004-01CTT01522021-02-26
10850003231638CellFXFG5007-01, FG6010-01CTT02522021-02-26
10850003231669CellFXFG5013-01, FG6016-01CTT05022021-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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