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510(k) Data Aggregation
K Number
K093653Manufacturer
Date Cleared
2010-02-23
(90 days)
Product Code
Regulation Number
876.5980Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Uresil Gastrostomy Catheter Kit is indicated for gastroenteric feeding or drainage.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for a medical device called the "Uresil Gastrostomy Catheter Kit". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the regulatory clearance process and substantial equivalence to predicate devices, rather than performance studies.
Therefore, I cannot provide the requested information based on the provided text.
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