Search Results
Found 2 results
510(k) Data Aggregation
K Number
K063753Device Name
GFX NERVE ABLATION SYSTEM
Manufacturer
ACI, INC.
Date Cleared
2007-06-20
(183 days)
Product Code
GXD, GXI
Regulation Number
882.4400Why did this record match?
Applicant Name (Manufacturer) :
ACI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lesion Probe and Generator system is intended to create radiofrequency (RF) heat lesions in nerve tissue. It is intended for use only by trained clinicians in a hospital or clinical setting.
Device Description
The GFX Nerve Ablation System provides a minimally invasive technique for creating a neural lesion inhibiting the function of the target nerve. The Generator and probe are used as a system to both stimulate the nerve for the purpose of locating the probe correctly and to create a neural lesion to inhibit nerve function through the application of RF energy. The GFX Nerve Ablation probes are single use devices supplied sterile to the customer.
Ask a Question
K Number
K061501Device Name
FLEXO DENTAL RESIN MATERIAL
Manufacturer
ACI, INC.
Date Cleared
2006-07-26
(56 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
ACI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Flexo Dental Resin Material is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
Device Description
The Flexo Dental Resin Material is an injection moldable, flexible thermoplastics resin designed for fabricating removable dental appliances.
Ask a Question
Page 1 of 1