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FDA 510(k)

VizMark Preloaded Tissue Marker Device (VM-0001)

K-Number: K251989 · 2025-12-12

ApplicantBreast-Med, Inc.
Decision Date2025-12-12
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VizMark Preloaded Tissue Marker Device (VM-0001) is a medical device manufactured by Breast-Med, Inc.. It received FDA 510(k) clearance on 2025-12-12 under approval number K251989. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VizMark Preloaded Tissue Marker Device (VM-0001)?

VizMark Preloaded Tissue Marker Device (VM-0001) is a medical device that received FDA 510(k) clearance on 2025-12-12. It is manufactured by Breast-Med, Inc.. The 510(k) number is K251989.

When was VizMark Preloaded Tissue Marker Device (VM-0001) approved by the FDA?

VizMark Preloaded Tissue Marker Device (VM-0001) received FDA 510(k) clearance on 2025-12-12, under approval number K251989.

What company makes VizMark Preloaded Tissue Marker Device (VM-0001)?

VizMark Preloaded Tissue Marker Device (VM-0001) is manufactured by Breast-Med, Inc..

What is the FDA product code for VizMark Preloaded Tissue Marker Device (VM-0001)?

The FDA product code for VizMark Preloaded Tissue Marker Device (VM-0001) is NEU.

Related Clinical Trials

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Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 41273038 Optimization of the Nonclinical Biological Evaluation of Medical Devices Using Toxicologic Pathology Best Practices. Advanced healthcare materials (2026) PMID: 41269675 Pathology as a Core Discipline in the Biological Evaluation of Medical Devices. International journal of toxicology (2026) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025)

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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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