Cleared Special

K142241 - LARIAT sulture Delivery Device

K142241 is an FDA 510(k) clearance for LARIAT sulture Delivery Device, manufactured by Sentreheart, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Special 510(k) pathway after a 30-day FDA review.

K142241 · Sentreheart, Inc. · General & Plastic Surgery device
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Sep 2014
Decision
30d
Days
Class 2
Risk

K142241 is an FDA 510(k) clearance for the LARIAT sulture Delivery Device. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Sentreheart, Inc. (Redwood City, US). The FDA issued a Cleared decision on September 12, 2014 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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 Sentreheart, Inc. devices

FDA 510(k) Submission Details - K142241

510(k) Number K142241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2014
Decision Date September 12, 2014
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

GAT Device Classification - Class 2, Special Controls

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 114
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K142241.
Nexus Suture
K151009 · Baylis Medical Company, Inc. · Aug 2015
Stryker Suture Tape
K150584 · Stryker · Aug 2015
Force Fiber OrthoTape suture
K150438 · Teleflexmedical, Inc. · Apr 2015
ARTHREX BIOSUTURE
K140019 · Arthrex, Inc. · Jan 2014
TFCC FAST-FIX KIT
K132079 · Smith & Nephew, Inc. · Dec 2013
SMITH & NEPHEW ULTRATAPE
K132357 · Smith & Nephew, Inc. · Oct 2013