510(k) clearance

Kerecis Express (50250)

FDA 510(k) source

510(k) number

K260058

Applicant

Kerecis Limited

Decision date

Oct 30, 2026

Date received

Jan 8, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

KGN

Device type

Wound Dressing With Animal-Derived Material(S)

Device class

Unclassified

Advisory committee

Unknown

Statement or summary

Summary

Third party

N

Location

Isafjordur, IS