Cleared Special

Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus

K251845 · Kerecis Limited · General & Plastic Surgery

Jul 2025

Decision

30d

Days

—

Risk

About This 510(k) Submission

K251845 is an FDA 510(k) clearance for the Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus, a Wound Dressing With Animal-derived Material(s), submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on July 16, 2025, 30 days after receiving the submission on June 16, 2025. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K251845 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2025
Decision Date	July 16, 2025
Days to Decision	30 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF