FDA 510(k)

Promogran Prisma™ 胶原基质，含 ORC 和银

K号: K251999 · 2026-03-13

决定日期2026-03-13

产品代码FRO

决定实质等同

器械摘要

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.

常见问题

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.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

Promogran Prisma™ 胶原基质，含 ORC 和银

器械摘要

常见问题

相关临床试验

相关器械（代码：FRO）

官方来源