Cleared Traditional

PROGRIP LAPARSCOPIC SELF-FIXATING MESH

K120897 · Sofradim Production · General & Plastic Surgery
Jun 2012
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K120897 is an FDA 510(k) clearance for the PROGRIP LAPARSCOPIC SELF-FIXATING MESH, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Sofradim Production (Bedford, US). The FDA issued a Cleared decision on June 29, 2012, 95 days after receiving the submission on March 26, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K120897 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2012
Decision Date June 29, 2012
Days to Decision 95 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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