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510(k) Data Aggregation
K Number
K990716Device Name
GALLINI BYCUT NEEDLEManufacturer
Date Cleared
1999-05-17
(74 days)
Product Code
Regulation Number
876.1075Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Gallini Bycut Needle is used for bone biopsy.
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) clearance letter from the FDA for a bone biopsy needle. It does not contain any information about acceptance criteria or a study that proves a device meets those criteria.
The letter only states that the device, the Gallini Bycut® Bone Biopsy Needle, is substantially equivalent to legally marketed predicate devices for bone biopsy and can therefore be marketed.
Therefore, I cannot provide the requested information.
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