Cleared Traditional

ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug

K151437 · Atrium Medical Corporation · General & Plastic Surgery
Aug 2015
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K151437 is an FDA 510(k) clearance for the ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Atrium Medical Corporation (Hudson, US). The FDA issued a Cleared decision on August 27, 2015, 90 days after receiving the submission on May 29, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K151437 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2015
Decision Date August 27, 2015
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

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

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