Cleared Special

K151112 - Quill Polypropylene Knotless Tissue-Clo...

K151112 is an FDA 510(k) clearance for Quill Polypropylene Knotless Tissue-Clo..., manufactured by Angiotech. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Special 510(k) pathway after a 135-day FDA review.

K151112 · Angiotech · General & Plastic Surgery device
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Sep 2015
Decision
135d
Days
Class 2
Risk

K151112 is an FDA 510(k) clearance for the Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Angiotech (Reading, US). The FDA issued a Cleared decision on September 10, 2015 after a review of 135 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Angiotech devices

FDA 510(k) Submission Details - K151112

510(k) Number K151112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2015
Decision Date September 10, 2015
Days to Decision 135 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 115d · This submission: 135d
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 42
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K151112.
REXLENE
K173747 · Sm Eng Co., Ltd. · Dec 2018
Aesculap Optilene Nonabsorbable Suture
K180321 · Aesculap, Inc. · Mar 2018
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
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
K133356 · Ethicon, Inc. · Dec 2013