Promogran Prisma Collagen Matrix with ORC and Silver— 510(k) K251999
Substantially EquivalentSolventum Germany GmbH
FDA 510(k) clearance K251999 for Promogran Prisma Collagen Matrix with ORC and Silver, Substantially Equivalent on 2026-03-13. Applicant: Solventum Germany GmbH. Device class: Unclassified.
Summary
Solventum Germany's Promogran Prisma Collagen Matrix with ORC and Silver is filed under FRO, drug wound dressings. The record doesn't list sizes or describe the matrix beyond its name and that code name.
The device class is listed as U, with no regulation number. The classification panel is listed as Unknown, and the General and Plastic Surgery review panel handled it as a Traditional 510(k).
Solventum Germany filed from Kamen, Germany. The decision came 259 calendar days after FDA received it (June 27, 2025 to March 13, 2026).
Clearance details
- Applicant
- Solventum Germany GmbH
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kamen, DE
Recent devices under product code FRO
view allAdverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.