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FDA 510(k)

LEKSELL NEURO GENERATOR AND ACCESSORIES

K-Number: K941823 · 1996-03-22

ApplicantElekta Instruments, Inc.
Decision Date1996-03-22
Product CodeGXD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LEKSELL NEURO GENERATOR AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Instruments, Inc.. It received FDA 510(k) clearance on 1996-03-22 under 510(k) number K941823. 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 LEKSELL NEURO GENERATOR AND ACCESSORIES?

LEKSELL NEURO GENERATOR AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1996-03-22. The listed applicant is Elekta Instruments, Inc.. The 510(k) number is K941823.

When did LEKSELL NEURO GENERATOR AND ACCESSORIES receive FDA 510(k) clearance?

LEKSELL NEURO GENERATOR AND ACCESSORIES received FDA 510(k) clearance on 1996-03-22, under 510(k) number K941823.

Who is the listed applicant for LEKSELL NEURO GENERATOR AND ACCESSORIES?

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

What is the FDA product code for LEKSELL NEURO GENERATOR AND ACCESSORIES?

The FDA product code for LEKSELL NEURO GENERATOR AND ACCESSORIES is GXD.

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Other records listing Elekta Instruments, 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.

K983678ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLEK955064SPETZLER TI 100 ANEURYSM CLIPK946165CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEMK943468LEKSELL SURGIPLANK932261ES-100 ACCESSORIESK925360ES-100 POWER SYSTEM, ES-100 SERIES

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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.

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