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510(k) Data Aggregation
K Number
K990231Device Name
WILTEK HOT BIOPSY FORCEPSManufacturer
Date Cleared
1999-04-13
(78 days)
Product Code
Regulation Number
876.4300Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Wiltek Hot Biopsy Forcep is intended for transendoscopic biopsy of the GI tract.
Device Description
Wiltek Hot Biopsy Forcep
AI/ML Overview
The provided documents are a 510(k) clearance letter and an Indications For Use statement for the Wiltek Hot Biopsy Forcep. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
Therefore, I cannot provide the requested information based on the input text.
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