Cleared Special

Kerecis SurgiBind (50241)

K251844 · Kerecis Limited · General & Plastic Surgery
Jul 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K251844 is an FDA 510(k) clearance for the Kerecis SurgiBind (50241), a Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery (Class II — Special Controls, product code OXH), submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on July 15, 2025, 29 days after receiving the submission on June 16, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K251844 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2025
Decision Date July 15, 2025
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code OXH — Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.