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FDA 510(k)

NEURO N 50 LESION GENERATOR

K-Number: K896450 · 1991-03-19

ApplicantLeibinger & Fischer , Ltd.
Decision Date1991-03-19
Product CodeGXD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEURO N 50 LESION GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Leibinger & Fischer , Ltd.. It received FDA 510(k) clearance on 1991-03-19 under 510(k) number K896450. 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 NEURO N 50 LESION GENERATOR?

NEURO N 50 LESION GENERATOR is a medical device that received FDA 510(k) clearance on 1991-03-19. The listed applicant is Leibinger & Fischer , Ltd.. The 510(k) number is K896450.

When did NEURO N 50 LESION GENERATOR receive FDA 510(k) clearance?

NEURO N 50 LESION GENERATOR received FDA 510(k) clearance on 1991-03-19, under 510(k) number K896450.

Who is the listed applicant for NEURO N 50 LESION GENERATOR?

The FDA 510(k) record lists Leibinger & Fischer , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEURO N 50 LESION GENERATOR?

The FDA product code for NEURO N 50 LESION GENERATOR 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 Leibinger & Fischer , Ltd. 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.

K892425STP COMPLETE MODULE SET

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

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

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