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FDA 510(k)

OES UROLOGY

K-Number: K950719 · 1996-12-11

ApplicantOlympus America, Inc.
Decision Date1996-12-11
Product CodeEZO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OES 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 1996-12-11 under 510(k) number K950719. The device is classified under product code EZO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OES UROLOGY?

OES UROLOGY is a medical device that received FDA 510(k) clearance on 1996-12-11. The listed applicant is Olympus America, Inc.. The 510(k) number is K950719.

When did OES UROLOGY receive FDA 510(k) clearance?

OES UROLOGY received FDA 510(k) clearance on 1996-12-11, under 510(k) number K950719.

Who is the listed applicant for OES 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 OES UROLOGY?

The FDA product code for OES UROLOGY is EZO.

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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: EZO)

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.

K000905URETHROTOME 8667.XXX AND 8670.XXXRichard Wolf Medical Instruments Corp.K945686KARL STORZ KNIVES, CURETTESKARL STORZ Endoscopy-America, Inc.K934730KARL STORZ ENDOSCOPIC COLD KNIFE BLADESKARL STORZ Endoscopy-America, Inc.K904939FLEXIBLE AND RIGID URETEROTOME SYSTEMOlympus Corp.

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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