Cleared Special

K133356 - PROLENE POLYPROPYLENE NONABSORBABLE SUTURE

K133356 is the FDA 510(k) clearance for PROLENE POLYPROPYLENE NONABSORBABLE SUTURE by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAW) cleared through the Special 510(k) pathway after a 36-day FDA review.

K133356 · Ethicon, Inc. · General & Plastic Surgery device
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Dec 2013
Decision
36d
Days
Class 2
Risk

K133356 is an FDA 510(k) clearance for the PROLENE POLYPROPYLENE NONABSORBABLE SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on December 6, 2013 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K133356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2013
Decision Date December 06, 2013
Days to Decision 36 days
Submission Type Special
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
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 21
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K133356.
Gazelle Polypropylene Suture and Delivery Device
K173644 · Dura Tap, LLC · Feb 2018
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
K141206 · Edwards Lifesciences, LLC · Jan 2015
AESCULAP OPTILENE NONABSORBABLE SUTURE
K133890 · Aesculap, Inc. · Jul 2014
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
K050947 · United States Surgical, A Division of Tyco Healthc · Jun 2005
AMS SLING FIXATION SYSTEM
K010990 · American Medical Systems, Inc. · Jun 2001
PRONOVA NONABSORBABLE SUTURE, USP
K001625 · Ethicon, Inc. · Jul 2000