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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 the device name listed in this FDA 510(k) record. The listed applicant is Breast-Med, Inc.. It received FDA 510(k) clearance on 2025-12-12 under 510(k) 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. The listed applicant is Breast-Med, Inc.. The 510(k) number is K251989.

When did VizMark Preloaded Tissue Marker Device (VM-0001) receive FDA 510(k) clearance?

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

Who is the listed applicant for VizMark Preloaded Tissue Marker Device (VM-0001)?

The FDA 510(k) record lists Breast-Med, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: NEU)

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.

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker EndoscopyK252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc.K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, Inc.K233639SmartClip Secure Soft Tissue MarkerElucent Medical, Inc.

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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