Cleared Abbreviated

K173335 - Gazelle PTFE and Suture Delivery Device

K173335 is an FDA 510(k) clearance for Gazelle PTFE and Suture Delivery Device, manufactured by Dura Tap, LLC. The device is a Class 2 General & Plastic Surgery device with product code NBY cleared through the Abbreviated 510(k) pathway after a 108-day FDA review.

K173335 · Dura Tap, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
108d
Days
Class 2
Risk

K173335 is an FDA 510(k) clearance for the Gazelle PTFE and Suture Delivery Device. Classified as Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (product code NBY), Class II - Special Controls.

Submitted by Dura Tap, LLC (Wayne, US). The FDA issued a Cleared decision on February 8, 2018 after a review of 108 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 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

FDA 510(k) Submission Details - K173335

510(k) Number K173335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2017
Decision Date February 08, 2018
Days to Decision 108 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
7d faster than avg
Panel avg: 115d · This submission: 108d
Pathway characteristics
Standards-based clearance path.

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 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.