Cleared Traditional

K082682 - SURGISIS BIODESIGN ENTEROCUTANEOUS FIST...

K082682 is the FDA 510(k) clearance for SURGISIS BIODESIGN ENTEROCUTANEOUS FIST... by Cook Biotech, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTM) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K082682 · Cook Biotech, Inc. · General & Plastic Surgery device
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Feb 2009
Decision
165d
Days
Class 2
Risk

K082682 is an FDA 510(k) clearance for the SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on February 27, 2009 after a review of 165 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.

View all Cook Biotech, Inc. devices

Submission Details

510(k) Number K082682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2008
Decision Date February 27, 2009
Days to Decision 165 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
50d slower than avg
Panel avg: 115d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTM Mesh, Surgical
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 - FTM Mesh, Surgical

All 58
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K082682.
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COLLAGEN TENDON WRAP
K080452 · Collagen Matrix, Inc. · May 2008
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08
K073219 · American Medical Systems, Inc. · Apr 2008