Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BNX FINE NEEDLE ASPIRATION SYSTEM

K-Number: K103668 · 2010-12-30

ApplicantBoston Endoscopic Engineering
Decision Date2010-12-30
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BNX FINE NEEDLE ASPIRATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Boston Endoscopic Engineering. It received FDA 510(k) clearance on 2010-12-30 under 510(k) number K103668. 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 BNX FINE NEEDLE ASPIRATION SYSTEM?

BNX FINE NEEDLE ASPIRATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-30. The listed applicant is Boston Endoscopic Engineering. The 510(k) number is K103668.

When did BNX FINE NEEDLE ASPIRATION SYSTEM receive FDA 510(k) clearance?

BNX FINE NEEDLE ASPIRATION SYSTEM received FDA 510(k) clearance on 2010-12-30, under 510(k) number K103668.

Who is the listed applicant for BNX FINE NEEDLE ASPIRATION SYSTEM?

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

What is the FDA product code for BNX FINE NEEDLE ASPIRATION SYSTEM?

The FDA product code for BNX FINE NEEDLE ASPIRATION SYSTEM 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

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.

↑