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510(k) Data Aggregation
K Number
K180725Device Name
Aspire Introducer Needle
Manufacturer
Aspire Bariatrics, Inc.
Date Cleared
2018-07-11
(113 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
Aspire Bariatrics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aspire Introducer Needle is intended to be used for guidewire introduction during percutaneous gastrointestinal procedures.
Device Description
The Aspire Introducer Needle is a single use, sterile, non-pyrogenic, disposable product used to provide initial percutaneous access. It is comprised of a stainless steel needle with a plastic sheath to be used in guidewire placement during percutaneous endoscopic procedures. The needle is used once the stomach is insufflated and the site verified through trans-illumination and visualization of finger indentation through the endoscope. The introducer needle is similar in design to other needles currently on the market for the same intended purpose. The dimensions of this device fall within the range of currently marketed introducer needles with the same intended use, and the materials are similar in that the needle is made from stainless steel and the other components are plastics. The device also incorporates a female luer lock hub in the design, also provided in the predicate devices.
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