Cleared Abbreviated

Gazelle Polypropylene Suture and Delivery Device (K173644) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K173644 · Dura Tap, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
80d
Days
Class 2
Risk

K173644 is an FDA 510(k) clearance for the Gazelle Polypropylene Suture and Delivery Device. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Dura Tap, LLC (Wayne, US). The FDA issued a Cleared decision on February 15, 2018 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dura Tap, LLC devices

Submission Details

510(k) Number K173644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2017
Decision Date February 15, 2018
Days to Decision 80 days
Submission Type Abbreviated
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
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 Consultant

Ambriel Associates, Inc.
Vikki M. O'Connor

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 20
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K173644.
Silhouette Featherlift / Silhouette Lift
K191299 · Silhouette Lift, Inc. · Jun 2019
REXLENE
K173747 · Sm Eng Co., Ltd. · Dec 2018
Aesculap Optilene Nonabsorbable Suture
K180321 · Aesculap, Inc. · Mar 2018
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
K141206 · Edwards Lifesciences, LLC · Jan 2015
AESCULAP OPTILENE NONABSORBABLE SUTURE
K133890 · Aesculap, Inc. · Jul 2014
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
K133356 · Ethicon, Inc. · Dec 2013