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FDA 510(k)

ECHO STAR NEEDLE SET

K-Number: K945921 · 1995-02-01

ApplicantIdeamatrix
Decision Date1995-02-01
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ECHO STAR NEEDLE SET is the device name listed in this FDA 510(k) record. The listed applicant is Ideamatrix. It received FDA 510(k) clearance on 1995-02-01 under 510(k) number K945921. 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 ECHO STAR NEEDLE SET?

ECHO STAR NEEDLE SET is a medical device that received FDA 510(k) clearance on 1995-02-01. The listed applicant is Ideamatrix. The 510(k) number is K945921.

When did ECHO STAR NEEDLE SET receive FDA 510(k) clearance?

ECHO STAR NEEDLE SET received FDA 510(k) clearance on 1995-02-01, under 510(k) number K945921.

Who is the listed applicant for ECHO STAR NEEDLE SET?

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

What is the FDA product code for ECHO STAR NEEDLE SET?

The FDA product code for ECHO STAR NEEDLE SET is FCG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ideamatrix 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.

K943368TRU-CORE NEEDLE SET

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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