Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus— 510(k) K251845

Substantially Equivalent

Kerecis Limited

FDA 510(k) clearance K251845 for Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus, Substantially Equivalent on 2025-07-16. Applicant: Kerecis Limited.

Clearance details

Applicant: Kerecis Limited
Product code: Code KGN
Advisory panel: Unknown
Date received: 2025-06-16
Decision date: 2025-07-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Isafjordur, IS

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.