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FDA 510(k)

3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY

K-Number: K943304 · 1995-12-20

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

Device Summary

3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY 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 K943304. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY?

3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY 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 K943304.

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

3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY received FDA 510(k) clearance on 1995-12-20, under 510(k) number K943304.

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

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 UROLOGY?

The FDA product code for 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY is FCG.

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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: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.

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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