FDA 510(k)

니كس알 안티미크로빌 솔루션™ 피부 및 상처 히드로젤

K-번호: K243457 · 2025-05-02

결정일2025-05-02

제품 코드FRO

결정대체적으로 동일

기기 요약

Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is the device name listed in this FDA 510(k) record. The listed applicant is Seriously Clean, Ltd.. It received FDA 510(k) clearance on 2025-05-02 under 510(k) number K243457. 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.

자주 묻는 질문

What is the Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel?

Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is a medical device that received FDA 510(k) clearance on 2025-05-02. The listed applicant is Seriously Clean, Ltd.. The 510(k) number is K243457.

When did Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel receive FDA 510(k) clearance?

Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel received FDA 510(k) clearance on 2025-05-02, under 510(k) number K243457.

Who is the listed applicant for Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel?

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

What is the FDA product code for Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel?

The FDA product code for Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is FRO. This falls under the Anesthesiology category.

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니كس알 안티미크로빌 솔루션™ 피부 및 상처 히드로젤

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FRO)

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