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510(k) Data Aggregation
K Number
K022268Device Name
HORIZONS REUSABLE POLYPECTOMY SNARESManufacturer
Date Cleared
2002-10-25
(102 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
Polypectomy Snares are used for cutting of polyps.
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) clearance letter from the FDA for a medical device called "Horizons Reusable Polypectomy Snares." This document is a regulatory approval and does not contain information about acceptance criteria, device performance studies, or details regarding AI algorithms.
Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not on clinical performance metrics or studies as typically described for AI device evaluations.
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