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FDA 510(k)

1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE

K-Number: K950705 · 1995-05-09

ApplicantNeuro Navigational Corp.
Decision Date1995-05-09
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE 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 1995-05-09 under 510(k) number K950705. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE?

1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1995-05-09. The listed applicant is Neuro Navigational Corp.. The 510(k) number is K950705.

When did 1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE receive FDA 510(k) clearance?

1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE received FDA 510(k) clearance on 1995-05-09, under 510(k) number K950705.

Who is the listed applicant for 1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE?

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 PREFORMED ENDOSCOPE?

The FDA product code for 1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE is HRX.

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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: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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