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510(k) Data Aggregation
K Number
K173644Device Name
Gazelle Polypropylene Suture and Delivery Device
Manufacturer
Dura Tap LLC
Date Cleared
2018-02-15
(80 days)
Product Code
GAW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
Dura Tap LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Gazelle™ Polypropylene Suture and Delivery Device is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures. Gazelle™ Polypropylene Suture and Delivery Device is provided sterile as a single use device.
Device Description
The Gazelle Polypropylene surgical sutures are sterile, nonabsorbable suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is pigmented blue (with [Phthalocyaninato(2-)] copper, Color Index Number 74160) to enhance visibility. The sutures are attached to a The Gazelle Suture Delivery Device is a Class I Manual Surgical Instrument that assists with suture placement. The Polypropylene suture is loaded into the Gazelle Delivery Device and is delivered to the desired location through the tip of the Gazelle Delivery Device. A standard knot pusher may be included with the Gazelle Polypropylene Suture and Delivery Device.
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K Number
K173335Device Name
Gazelle PTFE and Suture Delivery Device
Manufacturer
Dura Tap LLC
Date Cleared
2018-02-08
(108 days)
Product Code
NBY
Regulation Number
878.5035Why did this record match?
Applicant Name (Manufacturer) :
Dura Tap LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GazelleTM PTFE (polytetrafluroethylene) suture and Delivery Device is indicated for use in general soft tissue approximation and/or ligation, including; cardiovascular, dental, general surgical procedures and repair of the dura mater. Gazelle™PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. GazelleTM PTFE suture and Delivery Device is provided sterile as a single use device.
Device Description
The Gazelle PTFE surgical sutures are monofilament surgical sutures composed from expanded polytetrafluoroethylene (ePTFE) material. They are attached to a standard stainless steel surgical needle. The Gazelle Delivery Device is a Class I Manual Surgical Instrument that assists with suture placement. The PTFE suture is loaded into the Gazelle Delivery Device and is delivered to the desired location through the Gazelle device tip by pressing the actuation button on the Gazelle device handle.
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