Cleared Traditional

TroClose1200 (K160564) - FDA 510(k) Clearance

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

K160564 · Gordian Surgical, Ltd. · General & Plastic Surgery device
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Nov 2016
Decision
262d
Days
Class 2
Risk

K160564 is an FDA 510(k) clearance for the TroClose1200. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Gordian Surgical, Ltd. (Karmiel, IL). The FDA issued a Cleared decision on November 17, 2016 after a review of 262 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - 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 Gordian Surgical, Ltd. devices

Submission Details

510(k) Number K160564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2016
Decision Date November 17, 2016
Days to Decision 262 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
147d slower than avg
Panel avg: 115d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 63
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K160564.
REXMONO, PDREX
K173779 · Sm Eng Co., Ltd. · Mar 2018
Monosyn Quick Synthetic Absorbable Surgical Suture
K171001 · Aesculap, Inc. · Oct 2017
Novosyn Quick Absorbable Suture
K170661 · Aesculap, Inc. · Jun 2017
E-Pack Procedure Kit
K161726 · Ethicon, Inc. · Jul 2016
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
K151200 · Ethicon, Inc. · Aug 2015
PLIASURE Polyglycolide Synthetic Absorbable Suture
K142822 · Ethicon, Inc. · Mar 2015