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510(k) Data Aggregation
K Number
K183057Device Name
PUMA-G System
Manufacturer
CoapTech LLC
Date Cleared
2019-04-10
(159 days)
Product Code
KGC
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CoapTech LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults only.
Device Description
The PUMA-G System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed over the guidewire using the Sachs-Vine PUSH technique.
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