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FDA 510(k)

OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP

K-Number: K953290 · 1995-10-07

ApplicantOlympus America, Inc.
Decision Date1995-10-07
Product CodeKZD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP 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 1995-10-07 under 510(k) number K953290. The device is classified under product code KZD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP?

OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP is a medical device that received FDA 510(k) clearance on 1995-10-07. The listed applicant is Olympus America, Inc.. The 510(k) number is K953290.

When did OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP receive FDA 510(k) clearance?

OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP received FDA 510(k) clearance on 1995-10-07, under 510(k) number K953290.

Who is the listed applicant for OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP?

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 AUTOMATIC SURGICAL IRRIGATION PUMP?

The FDA product code for OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP is KZD.

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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: KZD)

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.

K974074INFUSION DYNAMICS POWER INFUSERInfusion Dynamics, Inc.K973843MSI PRESSURE INFUSORSmith Assoc.K951988PRESSURIZERPromedic, Inc.K942933PRESSURE INFUSION CUFFCirculatory Technology, Inc.K930012KAWASUMI LABORATORIES K-CUFFKawasumi Laboratories Co., Ltd.K921168ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000Allen Medical Systems, 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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