Cleared Traditional

'cottony' II TAPE, PLEDGETS (K153089) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153089 · Teleflexmedical, Inc. · General & Plastic Surgery device
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Aug 2016
Decision
291d
Days
Class 2
Risk

K153089 is an FDA 510(k) clearance for the 'cottony' II TAPE, PLEDGETS. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on August 12, 2016 after a review of 291 days - an extended review 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. 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 Teleflexmedical, Inc. devices

Submission Details

510(k) Number K153089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2015
Decision Date August 12, 2016
Days to Decision 291 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 115d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 81
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K153089.
PERMATAPE
K162247 · Medos International SARL · Dec 2016
XBraid TT Suture Tape
K162310 · Stryker · Nov 2016
SPEEDTRAP Graft Preparation System
K161638 · Medos International SARL · Nov 2016
ExpressBraid Graft Manipulation
K152868 · Biomet Manufacturing Corp · Feb 2016
Stryker Suture Tape
K150584 · Stryker · Aug 2015
ARTHREX BIOSUTURE
K140019 · Arthrex, Inc. · Jan 2014