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FDA 510(k)

SINGLE USE ASPIRATION NEEDLE NA-201SX-4022

K-Number: K050503 · 2005-05-12

ApplicantOlympus Medical Systems Corporation
Decision Date2005-05-12
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2005-05-12 under 510(k) number K050503. 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 SINGLE USE ASPIRATION NEEDLE NA-201SX-4022?

SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 is a medical device that received FDA 510(k) clearance on 2005-05-12. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K050503.

When did SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 receive FDA 510(k) clearance?

SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 received FDA 510(k) clearance on 2005-05-12, under 510(k) number K050503.

Who is the listed applicant for SINGLE USE ASPIRATION NEEDLE NA-201SX-4022?

The FDA 510(k) record lists Olympus Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE USE ASPIRATION NEEDLE NA-201SX-4022?

The FDA product code for SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 is FCG.

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Other records listing Olympus Medical Systems Corporation 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.

K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K260824Gastrointestinal Videoscope Olympus GIF-2T1500K260856Disposable Distal Attachment D-201-13404K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LBK252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

View all 86 devices →

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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