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FDA 510(k)

OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM

K-Number: K943305 · 1995-11-17

ApplicantOlympus America, Inc.
Decision Date1995-11-17
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1995-11-17 under 510(k) number K943305. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM?

OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-11-17. The listed applicant is Olympus America, Inc.. The 510(k) number is K943305.

When did OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM receive FDA 510(k) clearance?

OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM received FDA 510(k) clearance on 1995-11-17, under 510(k) number K943305.

Who is the listed applicant for OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM?

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

What is the FDA product code for OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM?

The FDA product code for OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM is HET.

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Other records listing Olympus America, Inc. 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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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Related Devices (Code: HET)

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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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