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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 the device name listed in this FDA 510(k) record. The listed applicant is Dura Tap, LLC. It received FDA 510(k) clearance on 2018-02-15 under 510(k) 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. The listed applicant is Dura Tap, LLC. The 510(k) number is K173644.

When did Gazelle Polypropylene Suture and Delivery Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Gazelle Polypropylene Suture and Delivery Device?

The FDA 510(k) record lists Dura Tap, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Dura Tap, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173335Gazelle PTFE and Suture Delivery Device

Related Devices (Code: GAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

Official Source

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

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