Cleared Traditional

K150668 - Biodesign Enterocutaneous Fistula Plug

K150668 is an FDA 510(k) clearance for Biodesign Enterocutaneous Fistula Plug, manufactured by Cook Biotech Incorprated. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K150668 · Cook Biotech Incorprated · General & Plastic Surgery device
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Dec 2015
Decision
268d
Days
Class 2
Risk

K150668 is an FDA 510(k) clearance for the Biodesign Enterocutaneous Fistula Plug. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Cook Biotech Incorprated (West Lafayette, US). The FDA issued a Cleared decision on December 9, 2015 after a review of 268 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 Incorprated devices

FDA 510(k) Submission Details - K150668

510(k) Number K150668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2015
Decision Date December 09, 2015
Days to Decision 268 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
153d slower than avg
Panel avg: 115d · This submission: 268d
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 144
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K150668.
Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft
K160869 · Cook Biotech Incorporated · Apr 2016
Endoform Reconstructive Template
K153633 · Aroa Biosurgery Limited (Formerly Mesynthes Limited) · Mar 2016
SurgiPure XD Reconstructive Tissue Matrix
K152206 · Tissue Regenix Group Plc · Mar 2016
SIS Inguinal Hernia Repair Graft
K142887 · Cook Biotech Incorprated · Oct 2015
LTM-Perforated Surgical Mesh
K150712 · Lifecell Corporation · Jul 2015
Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
K141084 · Acell, Inc. · Jun 2015