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510(k) Data Aggregation
K Number
K972781Device Name
OT-1Manufacturer
Date Cleared
1997-09-19
(56 days)
Product Code
Regulation Number
876.1500Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
To be used with an endoscope when repeated endoscopic intubation is anticipated; e.g. change of endoscopes or removal of multiple foreign bodies.
Device Description
OT-1 Endoscopic Overtube
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for the "OT-1 Endoscopic Overtube" device. It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
Therefore, I cannot provide the requested information based on the provided text.
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