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FDA 510(k)

OLYMPUS NA-10J-1 ASPIRATION NEEDLE

K-Number: K970563 · 1997-04-11

ApplicantOlympus America, Inc.
Decision Date1997-04-11
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS NA-10J-1 ASPIRATION NEEDLE 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 1997-04-11 under 510(k) number K970563. 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 OLYMPUS NA-10J-1 ASPIRATION NEEDLE?

OLYMPUS NA-10J-1 ASPIRATION NEEDLE is a medical device that received FDA 510(k) clearance on 1997-04-11. The listed applicant is Olympus America, Inc.. The 510(k) number is K970563.

When did OLYMPUS NA-10J-1 ASPIRATION NEEDLE receive FDA 510(k) clearance?

OLYMPUS NA-10J-1 ASPIRATION NEEDLE received FDA 510(k) clearance on 1997-04-11, under 510(k) number K970563.

Who is the listed applicant for OLYMPUS NA-10J-1 ASPIRATION NEEDLE?

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 NA-10J-1 ASPIRATION NEEDLE?

The FDA product code for OLYMPUS NA-10J-1 ASPIRATION NEEDLE 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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