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FDA 510(k)

3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY

K-Number: K943307 · 1995-12-20

ApplicantOlympus America, Inc.
Decision Date1995-12-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY 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 1995-12-20 under 510(k) number K943307. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY?

3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY is a medical device that received FDA 510(k) clearance on 1995-12-20. The listed applicant is Olympus America, Inc.. The 510(k) number is K943307.

When did 3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY receive FDA 510(k) clearance?

3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY received FDA 510(k) clearance on 1995-12-20, under 510(k) number K943307.

Who is the listed applicant for 3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY?

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 3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY?

The FDA product code for 3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY is GCJ.

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Other records listing Olympus America, Inc. as applicant

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

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Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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