FDA 510(k)

VizMark Preloaded Tissue Marker Device (VM-0001)

Номер K: K251989 · 2025-12-12

Дата решения2025-12-12

Код продуктаNEU

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: NEU)

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker Endoscopy K252892SCOUT 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.

Официальный источник

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