Cleared Traditional

Promogran Prisma? Collagen Matrix with ORC and Silver

K251999 · Solventum Germany GmbH · General & Plastic Surgery

Mar 2026

Decision

259d

Days

—

Risk

About This 510(k) Submission

K251999 is an FDA 510(k) clearance for the Promogran Prisma? Collagen Matrix with ORC and Silver, a Dressing, Wound, Drug, submitted by Solventum Germany GmbH (Kamen, DE). The FDA issued a Cleared decision on March 13, 2026, 259 days after receiving the submission on June 27, 2025. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K251999 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2025
Decision Date	March 13, 2026
Days to Decision	259 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF