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FDA 510(k)

iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)

K-Number: K221340 · 2023-03-02

ApplicantBoston Scientific Corporation
Decision Date2023-03-02
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-03-02 under approval number K221340. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)?

iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) is a medical device that received FDA 510(k) clearance on 2023-03-02. It is manufactured by Boston Scientific Corporation. The 510(k) number is K221340.

When was iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) approved by the FDA?

iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) received FDA 510(k) clearance on 2023-03-02, under approval number K221340.

What company makes iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)?

iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) is manufactured by Boston Scientific Corporation.

What is the FDA product code for iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)?

The FDA product code for iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) is EOQ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41827353 Clinical Trial Design and Regulatory Requirements for Artificial Intelligence as a Medical Device: A PRISMA-ScR-Guided Scoping Review of Global Guidance and Evidence (2017-2025). Journal of clinical medicine (2026)

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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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