Cleared Traditional

K170016 - Biodesign Fistula Plug

K170016 is an FDA 510(k) clearance for Biodesign Fistula Plug, manufactured by Cook Biotech Incorporated. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K170016 · Cook Biotech Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Jun 2017
Decision
169d
Days
Class 2
Risk

K170016 is an FDA 510(k) clearance for the Biodesign Fistula Plug. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Cook Biotech Incorporated (West Lafayette, US). The FDA issued a Cleared decision on June 21, 2017 after a review of 169 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 Incorporated devices

FDA 510(k) Submission Details - K170016

510(k) Number K170016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2017
Decision Date June 21, 2017
Days to Decision 169 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 115d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

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 67
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K170016.
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
K182259 · Acell, Inc. · Feb 2019
CanGaroo Neuro Envelope (small)
K182255 · Aziyo Biologics, Inc. · Nov 2018
Biodesign Diaphragmatic Hernia Graft
K171817 · Cook Biotech Incorporated · Mar 2018
SIS HERNIA GRAFT
K133306 · Cook Biotech, Inc. · Jul 2014
PERMACOL SURGICAL IMPLANT
K120605 · Covidien, LLC · May 2012
COLLAGEN RIBBON
K120019 · Wrightmedicaltechnologyinc · Feb 2012