Cleared Traditional

K133198 - ULTRAPRO COMFORT PLUG

K133198 is the FDA 510(k) clearance for ULTRAPRO COMFORT PLUG by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K133198 · Ethicon, Inc. · General & Plastic Surgery device
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May 2014
Decision
225d
Days
Class 2
Risk

K133198 is an FDA 510(k) clearance for the ULTRAPRO COMFORT PLUG. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on May 30, 2014 after a review of 225 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 Ethicon, Inc. devices

Submission Details

510(k) Number K133198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date May 30, 2014
Days to Decision 225 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
110d slower than avg
Panel avg: 115d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 135
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K133198.
Modified ONFLEX Mesh
K142706 · C.R. Bard, Inc. · Mar 2015
ONFLEX Mesh
K142711 · C.R. Bard, Inc. · Mar 2015
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
K141560 · Ethicon, Inc. · Oct 2014
BARD VENTRALEX HERNIA PATCH
K132441 · C.R. Bard, Inc. · Dec 2013
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K130968 · C.R. Bard, Inc. · May 2013
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K122436 · C.R. Bard, Inc. · Nov 2012