FDA 510(k)

Vashe Plus Antimicrobial Solution

Número K: K253665 · 2026-08-11

RequerenteUrgo Medical North America, LLC

Data da decisão2026-08-11

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vashe Plus Antimicrobial Solution is the device name listed in this FDA 510(k) record. The listed applicant is Urgo Medical North America, LLC. It received FDA 510(k) clearance on 2026-08-11 under 510(k) number K253665. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vashe Plus Antimicrobial Solution?

Vashe Plus Antimicrobial Solution is a medical device that received FDA 510(k) clearance on 2026-08-11. The listed applicant is Urgo Medical North America, LLC. The 510(k) number is K253665.

When did Vashe Plus Antimicrobial Solution receive FDA 510(k) clearance?

Vashe Plus Antimicrobial Solution received FDA 510(k) clearance on 2026-08-11, under 510(k) number K253665.

Who is the listed applicant for Vashe Plus Antimicrobial Solution?

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

What is the FDA product code for Vashe Plus Antimicrobial Solution?

The FDA product code for Vashe Plus Antimicrobial Solution is FRO. This falls under the Anesthesiology category.

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