Cleared Special

K133356 - PROLENE POLYPROPYLENE NONABSORBABLE SUTURE

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

K133356 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K133356

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.

GAW Device Classification - Class 2, Special Controls

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 84
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K133356.
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
K141206 · Edwards Lifesciences, LLC · Jan 2015
StitchKit
K142639 · Origami Surgical, LLC · Dec 2014
AESCULAP OPTILENE NONABSORBABLE SUTURE
K133890 · Aesculap, Inc. · Jul 2014
SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE
K131224 · Surgical Specialties Corp. Dba Angiotech · May 2013
QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K130078 · Surgical Specialties Corp. Dba Angiotech · Feb 2013
NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA
K113494 · Nobles Medical Technologies Ii, Inc. · Apr 2012
K133356 · PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
Download PDF FDA Summary Ethicon, Inc.