FDA 510(k)

프로모그란 프리즘™ 코λλ라젠 매트릭스 ORC 및 실버

K-번호: K251999 · 2026-03-13

결정일2026-03-13

제품 코드FRO

결정대체적으로 동일

기기 요약

Promogran Prisma™ Collagen Matrix with ORC and Silver is the device name listed in this FDA 510(k) record. The listed applicant is Solventum Germany GmbH. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K251999. 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 Promogran Prisma™ Collagen Matrix with ORC and Silver?

Promogran Prisma™ Collagen Matrix with ORC and Silver is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Solventum Germany GmbH. The 510(k) number is K251999.

When did Promogran Prisma™ Collagen Matrix with ORC and Silver receive FDA 510(k) clearance?

Promogran Prisma™ Collagen Matrix with ORC and Silver received FDA 510(k) clearance on 2026-03-13, under 510(k) number K251999.

Who is the listed applicant for Promogran Prisma™ Collagen Matrix with ORC and Silver?

The FDA 510(k) record lists Solventum Germany GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Promogran Prisma™ Collagen Matrix with ORC and Silver?

The FDA product code for Promogran Prisma™ Collagen Matrix with ORC and Silver is FRO. This falls under the Anesthesiology category.

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프로모그란 프리즘™ 코λλ라젠 매트릭스 ORC 및 실버

기기 요약

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관련 임상시험

관련 기기 (코드: FRO)

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