Cleared Special

OviTex PRS

K241126 · TELA Bio, Inc. · General & Plastic Surgery
May 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K241126 is an FDA 510(k) clearance for the OviTex PRS, a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by TELA Bio, Inc. (Malvern, US). The FDA issued a Cleared decision on May 22, 2024, 29 days after receiving the submission on April 23, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K241126 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2024
Decision Date May 22, 2024
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FTM — Mesh, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300