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510(k) Data Aggregation
(179 days)
CORGRIP* SR NG/NI Tube Retention System
The CORGRIP* SR Nasogastric/Nasointestinal (NG/N) 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 of displacement of the tubes for adult patients.
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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes used for testing/training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or the type of ground truth used.
The document is an FDA clearance letter for a medical device (CORGRIP* SR NG/NI Tube Retention System). It confirms the device's substantial equivalence to legally marketed predicate devices and outlines regulatory requirements for the manufacturer. It specifies the indications for use but does not delve into the studies or data used to establish that equivalence or any performance metrics.
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