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510(k) Data Aggregation
K Number
K242668Device Name
Gastro Concepts Air Assist
Manufacturer
Gastro Concepts, LLC
Date Cleared
2024-12-13
(99 days)
Product Code
FER, FED
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Gastro Concepts, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Air Assist is intended to slide over the outer surface of an endoscope to facilitate endoscopic therapy by providing a manual, reversible method to control the insufflation (air/CO2) so the physician can better maintain an appropriate field of view.
Device Description
The Gastro Concepts Air Assist Device is a single-use device that is used to aid in maintaining air/CO2 and insufflation during a colonoscopy. The Air Assist, a single-use device, comprises a cylindrical body with a conical-shaped tip and an open channel for endoscope insertion. Positioned against the anus (not inserted into the rectum), it forms a temporary seal, maintaining air/CO2 insufflation leading to adequate colonic distension for enhanced visualization.
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