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FDA 510(k)

Gazelle PTFE and Suture Delivery Device

K-Number: K173335 · 2018-02-08

ApplicantDura Tap, LLC
Decision Date2018-02-08
Product CodeNBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Gazelle PTFE and Suture Delivery Device is a medical device manufactured by Dura Tap, LLC. It received FDA 510(k) clearance on 2018-02-08 under approval number K173335. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gazelle PTFE and Suture Delivery Device?

Gazelle PTFE and Suture Delivery Device is a medical device that received FDA 510(k) clearance on 2018-02-08. It is manufactured by Dura Tap, LLC. The 510(k) number is K173335.

When was Gazelle PTFE and Suture Delivery Device approved by the FDA?

Gazelle PTFE and Suture Delivery Device received FDA 510(k) clearance on 2018-02-08, under approval number K173335.

What company makes Gazelle PTFE and Suture Delivery Device?

Gazelle PTFE and Suture Delivery Device is manufactured by Dura Tap, LLC.

What is the FDA product code for Gazelle PTFE and Suture Delivery Device?

The FDA product code for Gazelle PTFE and Suture Delivery Device is NBY.

Related Clinical Trials

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Related PubMed Literature

PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026) PMID: 40553217 Device reps in theatre: blurred boundaries or regulatory gaps? Monash bioethics review (2025) PMID: 39855465 [Review of practices concerning the delivery of an international implant card following the implantation of a medical device]. Annales pharmaceutiques francaises (2025)

Other Devices by Dura Tap, LLC

K173644Gazelle Polypropylene Suture and Delivery Device

Related Devices (Code: NBY)

K160744LOOK PTFE SutureSurgical Specialties Corporation K170842WEGO-PTFEFoosin Medical Supplies Inc., Ltd. K163049GOLNIT Non-Absorbable PTFE Surgical SutureAntarma Dba Golnit Sutures K163639LS-5 ePTFE SutureLsi Solutions K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation K180630PTFE SURGICAL SUTUREOmnia Spa

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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