Cleared Traditional

Kerecis Reconstruct

K202430 · Kerecis Limited · General & Plastic Surgery
May 2021
Decision
250d
Days
Class 2
Risk

About This 510(k) Submission

K202430 is an FDA 510(k) clearance for the Kerecis Reconstruct, 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 May 2, 2021, 250 days after receiving the submission on August 25, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K202430 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2020
Decision Date May 02, 2021
Days to Decision 250 days
Submission Type Traditional
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.