Cleared Special

PARIETEX PROGRIP

K103682 · Sofradim Production · General & Plastic Surgery
Mar 2011
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K103682 is an FDA 510(k) clearance for the PARIETEX PROGRIP, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Sofradim Production (Bedford, US). The FDA issued a Cleared decision on March 4, 2011, 77 days after receiving the submission on December 17, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K103682 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2010
Decision Date March 04, 2011
Days to Decision 77 days
Submission Type Special
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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