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FDA 510(k)

1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES

K-Number: K950154 · 1995-07-14

ApplicantNeuro Navigational Corp.
Decision Date1995-07-14
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES 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 1995-07-14 under 510(k) number K950154. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES?

1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Neuro Navigational Corp.. The 510(k) number is K950154.

When did 1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES receive FDA 510(k) clearance?

1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES received FDA 510(k) clearance on 1995-07-14, under 510(k) number K950154.

Who is the listed applicant for 1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES?

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 1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES?

The FDA product code for 1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES is GWG.

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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: GWG)

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.

K253602Precision S 4K SinuscopeStryker EndoscopyK253679Hydro Irrigation SystemStryker InstrumentsK243429HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd.K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)Integra LifeSciences CorporationK233391cCeLL - In vivoVPIX Medical, Inc.K223615Digital ClarusScope System, Digital NeuroPEN SystemClarus Medical, LLC

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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