Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Gazelle Polypropylene Suture and Delivery Device

K-Number: K173644 · 2018-02-15

ApplicantDura Tap, LLC
Decision Date2018-02-15
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Gazelle Polypropylene Suture and Delivery Device is a medical device manufactured by Dura Tap, LLC. It received FDA 510(k) clearance on 2018-02-15 under approval number K173644. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gazelle Polypropylene Suture and Delivery Device?

Gazelle Polypropylene Suture and Delivery Device is a medical device that received FDA 510(k) clearance on 2018-02-15. It is manufactured by Dura Tap, LLC. The 510(k) number is K173644.

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

Gazelle Polypropylene Suture and Delivery Device received FDA 510(k) clearance on 2018-02-15, under approval number K173644.

What company makes Gazelle Polypropylene Suture and Delivery Device?

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

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

The FDA product code for Gazelle Polypropylene Suture and Delivery Device is GAW.

Related Clinical Trials

NCT06511414 Effect of Duramesh™ on Hernia Formation After Ileostomy Closure ACTIVE_NOT_RECRUITING NCT07595835 CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer RECRUITING NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING NCT07595289 DP-DCT 1.0：A Comparative Clinical Study on the Effect of Dapagliflozin Combined With CGM Versus SMBG on Glycemic Control in Patients With Type 2 Diabetes Mellitus Based on the DP-DCT Platform NOT_YET_RECRUITING NCT07558291 Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Women With Gestational Diabetes NOT_YET_RECRUITING NCT06024928 Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes COMPLETED

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

K173335Gazelle PTFE and Suture Delivery Device

Related Devices (Code: GAW)

K160529Pledgeted COR-SUTURE QUICK LOADLsi Soultions K171039Assut Filbloc Permanent SuturesAssut Europe S.P.A. K171005Silhouette FeatherliftSilhouette Lift, Inc. K162617NobleStitch ELNobles Medical Technologies Ii, Inc. K173747REXLENESm Eng Co., Ltd. K180321Aesculap Optilene Nonabsorbable SutureAesculap, Inc.

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.

↑