Cleared Traditional

K151009 - Nexus Suture

K151009 is an FDA 510(k) clearance for Nexus Suture, manufactured by Baylis Medical Company, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K151009 · Baylis Medical Company, Inc. · General & Plastic Surgery device
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Aug 2015
Decision
125d
Days
Class 2
Risk

K151009 is an FDA 510(k) clearance for the Nexus Suture. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Baylis Medical Company, Inc. (Mississauga, CA). The FDA issued a Cleared decision on August 18, 2015 after a review of 125 days - within the typical 510(k) review window.

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. 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 Baylis Medical Company, Inc. devices

FDA 510(k) Submission Details - K151009

510(k) Number K151009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2015
Decision Date August 18, 2015
Days to Decision 125 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
10d slower than avg
Panel avg: 115d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 141
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K151009.
ExpressBraid Graft Manipulation
K152868 · Biomet Manufacturing Corp · Feb 2016
LARIAT RS Suture Delivery Device
K153096 · Sentreheart, Inc. · Nov 2015
ALAR Nasal Valve Stent
K151758 · Medtronic Xomed, Inc. · Oct 2015
Stryker Suture Tape
K150584 · Stryker · Aug 2015
NovoStitch Plus Meniscal Repair System
K143356 · Ceterix Orthopaedics, Inc. · Jul 2015
Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2
K150327 · Dunamis, LLC · Jun 2015