FDA 510(k)

Promogran Prisma Collagen Matrix with ORC and Silver

K-Number: K251999 · 2026-03-13

Decision Date2026-03-13

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

Promogran Prisma Collagen Matrix with ORC and Silver is a medical device manufactured by Solventum Germany GmbH. It received FDA 510(k) clearance on 2026-03-13 under approval 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.

Frequently Asked Questions

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. It is manufactured by Solventum Germany GmbH. The 510(k) number is K251999.

When was Promogran Prisma Collagen Matrix with ORC and Silver approved by the FDA?

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

What company makes Promogran Prisma Collagen Matrix with ORC and Silver?

Promogran Prisma Collagen Matrix with ORC and Silver is manufactured by Solventum Germany GmbH.

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.