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FDA 510(k)

BRAIN PORT

K-Number: K120691 · 2012-06-05

ApplicantNico Corporation
Decision Date2012-06-05
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRAIN PORT is the device name listed in this FDA 510(k) record. The listed applicant is Nico Corporation. It received FDA 510(k) clearance on 2012-06-05 under 510(k) number K120691. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAIN PORT?

BRAIN PORT is a medical device that received FDA 510(k) clearance on 2012-06-05. The listed applicant is Nico Corporation. The 510(k) number is K120691.

When did BRAIN PORT receive FDA 510(k) clearance?

BRAIN PORT received FDA 510(k) clearance on 2012-06-05, under 510(k) number K120691.

Who is the listed applicant for BRAIN PORT?

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

What is the FDA product code for BRAIN PORT?

The FDA product code for BRAIN PORT is GZT.

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Other records listing Nico Corporation 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.

K232567Myriad SPECTRA Light SourceK191599NICO Myriad NOVUSK182340NICO MyriadK172433NICO BrainPathK161307NICO MyriadK162075NICO TRIOwand

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Related Devices (Code: GZT)

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.

K252995Durashield Device KitSurGenTec, LLCK210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc.K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)Vycor Medical, Inc.K202072MindsEye Expandable PortMinnetronix Neuro, Inc.K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbHK172433NICO BrainPathNico Corporation

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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