Cleared Traditional

K050337 - SIS FISTULA PLUG

K050337 is the FDA 510(k) clearance for SIS FISTULA PLUG 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 27-day FDA review.

K050337 · Cook Biotech, Inc. · General & Plastic Surgery device
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Mar 2005
Decision
27d
Days
Class 2
Risk

K050337 is an FDA 510(k) clearance for the SIS 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 March 9, 2005 after a review of 27 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Biotech, Inc. devices

Submission Details

510(k) Number K050337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2005
Decision Date March 09, 2005
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
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 K050337.
SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
K051879 · Synthes (Usa) · Oct 2005
SURGISIS STAPLE LINE REINFORCEMENT II
K051048 · Cook Biotech, Inc. · Sep 2005
SIS DERMAL AUGMENTATION STRAND
K050246 · Cook Biotech, Inc. · May 2005
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
K040756 · Implex Corp. · Jul 2004
SIS PLASTIC SURGERY MATRIX
K034039 · Cook Biotech, Inc. · Feb 2004
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K031969 · DePuy Orthopaedics, Inc. · Jul 2003