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510(k) K251999

Promogran Prisma™ Collagen Matrix with ORC and Silver by Solventum Germany GmbH — Product Code FRO

K251999 is an FDA 510(k) premarket notification submitted by Solventum Germany GmbH for the device "Promogran Prisma™ Collagen Matrix with ORC and Silver". The FDA issued a decision of Substantially Equivalent on March 13, 2026. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2026
Date Received
June 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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FDA data resources