Cleared Traditional

K071470 - IMPLANTECH EPTFE SHEETING

K071470 is the FDA 510(k) clearance for IMPLANTECH EPTFE SHEETING by Implantech Associates, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

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

K071470 is an FDA 510(k) clearance for the IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Implantech Associates, Inc. (Ventura, US). The FDA issued a Cleared decision on August 31, 2007 after a review of 94 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Implantech Associates, Inc. devices

Submission Details

510(k) Number K071470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 115d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 158
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K071470.
GORE INFINIT MESH
K081069 · W.L. Gore & Associates, Inc. · May 2008
C-QUR LITE MESH V-PATCH
K080688 · Atrium Medical Corp. · Apr 2008
C-QUR EDGE MESH V-PATCH
K080691 · Atrium Medical Corp. · Apr 2008
ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
K071249 · Ethicon, Inc. · Jun 2007
TOPAS SYSTEM
K070993 · American Medical Systems, Inc. · May 2007
ULTRAPRO PLUG
K070224 · Ethicon, Inc. · Apr 2007