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510(k) Data Aggregation
K Number
K191067Device Name
Arc Endocuff Glide AEG110 & AEG120Manufacturer
Date Cleared
2019-05-30
(38 days)
Product Code
Regulation Number
876.1500Type
SpecialReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:
- keeping the suitable depth of endoscope's view field
- helping the endoscope with being inserted into the gastrointestinal tract
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for a medical device called "Arc Endocuff Glide AEG110 & AEG120." It primarily addresses the regulatory approval of the device and its indications for use. It does not contain information about acceptance criteria, device performance study details, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval notice, not a study report or technical specification.
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