Cleared Traditional

K160744 - LOOK PTFE Suture

K160744 is an FDA 510(k) clearance for LOOK PTFE Suture, manufactured by Surgical Specialties Corporation. The device is a Class 2 General & Plastic Surgery device with product code NBY cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K160744 · Surgical Specialties Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
118d
Days
Class 2
Risk

K160744 is an FDA 510(k) clearance for the LOOK PTFE Suture. Classified as Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (product code NBY), Class II - Special Controls.

Submitted by Surgical Specialties Corporation (Tijuana, MX). The FDA issued a Cleared decision on July 13, 2016 after a review of 118 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5035 - 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.

FDA 510(k) Submission Details - K160744

510(k) Number K160744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2016
Decision Date July 13, 2016
Days to Decision 118 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
3d slower than avg
Panel avg: 115d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBY Device Classification - Class 2, Special Controls

Product Code NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5035
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 - NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

All 16
Devices cleared under the same product code (NBY) and FDA review panel - the closest regulatory comparables to K160744.
WEGO-PTFE
K170842 · Foosin Medical Supplies Inc., Ltd. · Jul 2017
GOLNIT Non-Absorbable PTFE Surgical Suture
K163049 · Antarma Dba Golnit Sutures · Jun 2017
LS-5 ePTFE Suture
K163639 · Lsi Solutions · Jun 2017
MONOTEX
K140415 · Riverpoint Medical · Mar 2014
PTFE SURGICAL SUTURE
K132464 · Omnia Spa · Feb 2014
STITCHKIT
K123811 · Origami Surgical, LLC · Sep 2013