K241080 - Kerecis Parvus (50207) (FDA 510(k) Clearance)

K241080 is an FDA 510(k) clearance for the Kerecis Parvus (50207). Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on August 21, 2024 after a review of 124 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Kerecis Limited devices