Cleared Traditional

K071695 - KENSEY NASH MACROPORE SHIELD

K071695 is an FDA 510(k) clearance for KENSEY NASH MACROPORE SHIELD, manufactured by Kensey Nash Corp.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K071695 · Kensey Nash Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
194d
Days
Class 2
Risk

K071695 is an FDA 510(k) clearance for the KENSEY NASH MACROPORE SHIELD. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Kensey Nash Corp. (Exton, US). The FDA issued a Cleared decision on December 31, 2007 after a review of 194 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K071695

510(k) Number K071695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2007
Decision Date December 31, 2007
Days to Decision 194 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 115d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

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 335
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K071695.
BIOMERIX SURGICAL MESH, MODEL: RCR-01
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K063091 · Tyrx Pharma, Inc. · Jan 2008
ORTHO-WRAP BIORESORBABLE SHEET
K072190 · Mast Biosurgery · Jan 2008
TEPHAFLEX SURGICAL FILM
K072520 · Tepha, Inc. · Nov 2007
SPORTMESH OR ARTELON TISSUE REINFORCEMENT
K071887 · Artimplant AB · Sep 2007
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
K071470 · Implantech Associates, Inc. · Aug 2007