Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GFX NERVE ABLATION SYSTEM

K-Number: K063753 · 2007-06-20

ApplicantAci, Inc.
Decision Date2007-06-20
Product CodeGXD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GFX NERVE ABLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aci, Inc.. It received FDA 510(k) clearance on 2007-06-20 under 510(k) number K063753. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GFX NERVE ABLATION SYSTEM?

GFX NERVE ABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-06-20. The listed applicant is Aci, Inc.. The 510(k) number is K063753.

When did GFX NERVE ABLATION SYSTEM receive FDA 510(k) clearance?

GFX NERVE ABLATION SYSTEM received FDA 510(k) clearance on 2007-06-20, under 510(k) number K063753.

Who is the listed applicant for GFX NERVE ABLATION SYSTEM?

The FDA 510(k) record lists Aci, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GFX NERVE ABLATION SYSTEM?

The FDA product code for GFX NERVE ABLATION SYSTEM is GXD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Aci, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061501FLEXO DENTAL RESIN MATERIAL

Related Devices (Code: GXD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)Boston Scientific Neuromodulation CorporationK242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)Avanos Medical, Inc.K232632Racz Neurostat RF GeneratorEpimed InternationalK231675OneRF Ablation SystemNeuroone Medical Technologies Corp.K220122APEX 6Rf Innovations, Inc.K203293Abbott Medical Grounding Pad, model RF-DGP-ISABBOTT MEDICAL

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑