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510(k) Data Aggregation
K Number
K162110Device Name
CORGRIP NG/NI Tube Retention System
Manufacturer
CORPAK MedSystems, Inc. a Division of Haylard Health
Date Cleared
2016-09-15
(48 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CORPAK MedSystems, Inc. a Division of Haylard Health
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORGRIP Nasogastric/Nasointestinal (NGNI) Tube Retention System is indicated for use with enteral feeding tubes of 8 FR and greater and NG decompression, suction and drainage tubes up to 18 FR to prevent inadvertent removal or displacement of the tubes for adult patients.
Device Description
The CORGRIP NG/NI Tube Retention System is an accessary to prevent unwanted displacement or removal of nasogastric/nasojejunal tubes for adult patients by retaining the tube to the patient's nasal septum. The device consists of three main components: insertion (delivery) catheter, retrieval catheter, and tube clamp.
The catheters are placed in either nare of the patient and the clinician maneuvers the catheters to connect the magnets at the back of the patient's nasal septum. Both catheters have a flexible tip to aid in magnet connection. Once connection is made the magnet on the insertion catheter is pulled through the nare by the retrieval catheter. Both catheters are then removed from each nare until the ends of the umbilical tape are exiting either nare. The umbilical tape is then secured to the feeding tube with the provided clamp.
The proposed device adds the option of a 14, 16 and 18 Fr clamp.
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