FDA 510(k)

VacHeal Negative Pressure Wound Therapy System

Номер K: K254160 · 2026-09-18

ЗаявительVacHeal, LLC

Дата решения2026-09-18

Код продуктаOKO

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

VacHeal Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is VacHeal, LLC. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K254160. The device is classified under product code OKO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the VacHeal Negative Pressure Wound Therapy System?

VacHeal Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is VacHeal, LLC. The 510(k) number is K254160.

When did VacHeal Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

VacHeal Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2026-09-18, under 510(k) number K254160.

Who is the listed applicant for VacHeal Negative Pressure Wound Therapy System?

The FDA 510(k) record lists VacHeal, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VacHeal Negative Pressure Wound Therapy System?

The FDA product code for VacHeal Negative Pressure Wound Therapy System is OKO.

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: OKO)

K251156NPsealGuard Medical, Inc.K250708NPsealGuard Medical, Inc.K241522NPseal (20 and 25)Guard Medical, Inc.K240244NPseal (Small, Medium, Large)Guard Medical, Inc.K212971NPsealGuard Medical, Inc.K211130NPsealGuard Medical, Inc.

Официальный источник

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