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FDA 510(k)

OLYMPUS NEURO ENDOSCOPE

K-Number: K971340 · 1998-07-29

ApplicantOlympus Optical, Co.
Decision Date1998-07-29
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OLYMPUS NEURO ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Optical, Co.. It received FDA 510(k) clearance on 1998-07-29 under 510(k) number K971340. 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 OLYMPUS NEURO ENDOSCOPE?

OLYMPUS NEURO ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1998-07-29. The listed applicant is Olympus Optical, Co.. The 510(k) number is K971340.

When did OLYMPUS NEURO ENDOSCOPE receive FDA 510(k) clearance?

OLYMPUS NEURO ENDOSCOPE received FDA 510(k) clearance on 1998-07-29, under 510(k) number K971340.

Who is the listed applicant for OLYMPUS NEURO ENDOSCOPE?

The FDA 510(k) record lists Olympus Optical, Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS NEURO ENDOSCOPE?

The FDA product code for OLYMPUS NEURO ENDOSCOPE is GWG.

Related Clinical Trials

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Other records listing Olympus Optical, Co. 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.

K990687HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPSK982610OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT)K962952OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)

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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