Cleared Traditional

IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX

K071470 · Implantech Associates, Inc. · General & Plastic Surgery
Aug 2007
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K071470 is an FDA 510(k) clearance for the IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Implantech Associates, Inc. (Ventura, US). The FDA issued a Cleared decision on August 31, 2007, 94 days after receiving the submission on May 29, 2007. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K071470 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2007
Decision Date August 31, 2007
Days to Decision 94 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

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

Similar Devices — FTL Mesh, Surgical, Polymeric

All 334
Parietene? Flat Sheet Mesh
K253125 · Medtronic - Sofradim Production · Oct 2025
Onflex? Mesh
K251955 · Davol Inc., Subsidiary of C. R. Bard, Inc. · Jul 2025
Bard? Mesh; Bard? Mesh Pre-Shaped
K251557 · Davol, Inc. · Jun 2025
Parietene? Macroporous Mesh (PPM5050 )
K250869 · Sofradim Production · Apr 2025
Bard Soft Mesh; Bard Soft Mesh Pre-Shaped
K250098 · Davol, Inc. · Apr 2025
ProGrip? Self-Gripping Polypropylene Mesh
K243315 · Sofradim Production · Jan 2025