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FDA 510(k)

AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)

K-Number: K260255 · 2026-03-27

ApplicantAventix Medical, Inc.
Decision Date2026-03-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) is a medical device manufactured by Aventix Medical, Inc.. It received FDA 510(k) clearance on 2026-03-27 under approval number K260255. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)?

AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) is a medical device that received FDA 510(k) clearance on 2026-03-27. It is manufactured by Aventix Medical, Inc.. The 510(k) number is K260255.

When was AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) approved by the FDA?

AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) received FDA 510(k) clearance on 2026-03-27, under approval number K260255.

What company makes AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)?

AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) is manufactured by Aventix Medical, Inc..

What is the FDA product code for AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)?

The FDA product code for AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) is GEI.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

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Official Source

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