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FDA 510(k)

NEUROVIEW COAXIAL BIPOLAR ELECTRODE

K-Number: K955467 · 1995-12-18

ApplicantNeuro Navigational Corp.
Decision Date1995-12-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEUROVIEW COAXIAL BIPOLAR ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Neuro Navigational Corp.. It received FDA 510(k) clearance on 1995-12-18 under 510(k) number K955467. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROVIEW COAXIAL BIPOLAR ELECTRODE?

NEUROVIEW COAXIAL BIPOLAR ELECTRODE is a medical device that received FDA 510(k) clearance on 1995-12-18. The listed applicant is Neuro Navigational Corp.. The 510(k) number is K955467.

When did NEUROVIEW COAXIAL BIPOLAR ELECTRODE receive FDA 510(k) clearance?

NEUROVIEW COAXIAL BIPOLAR ELECTRODE received FDA 510(k) clearance on 1995-12-18, under 510(k) number K955467.

Who is the listed applicant for NEUROVIEW COAXIAL BIPOLAR ELECTRODE?

The FDA 510(k) record lists Neuro Navigational Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROVIEW COAXIAL BIPOLAR ELECTRODE?

The FDA product code for NEUROVIEW COAXIAL BIPOLAR ELECTRODE is GEI.

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Other records listing Neuro Navigational Corp. 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.

K9650782.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPSK961406NEUROVIEW SCISSORSK9611731.2MM REUSABLE NEUROVIEW ENDOSCOPEK961300ASPIRATION/IRRIGATION CATHETERK960792DISPOSABLE NEUROVIEW INTRODUCER SHEATHK954938DISPOSABLE NEUROVIEW OPERATING SHEATH

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Related Devices (Code: GEI)

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.

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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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