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510(k) Data Aggregation
K Number
K231323Device Name
Ancora-SB
Manufacturer
Aspero Medical, Inc.
Date Cleared
2023-08-31
(115 days)
Product Code
FDA, FED
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Aspero Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ancora-SB is an accessory to an endoscope. The Ancora-SB is intended for use with any standard endoscope that has an outer diameter of 9.0 - 9.4 mm and a working length of 1680 mm or greater. The Ancora-SB is intended for use with any standard flexible endoscopy balloon inflation unit with a set pressure of 5.4 kPa (+2.6 kPa, -1.8 kPa). The device is indicated to ensure complete positioning of an endoscope in the small intestine by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment.
Device Description
The Ancora-SB is a single-use, close-fitting sleeve that slides freely over a currently marketed standard endoscope having an outer diameter of 9.0 – 9.4 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the small intestine, by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment. The device is designed to be used with a Balloon Endoscopy System (BES) which includes a multi-channel endoscope, an endoscopy tower (light source, display monitor, recording equipment, etc.) and a balloon inflation unit (equipment that inflates or deflates by a push button control, inflation is to a stated maximum pressure and the pressure is maintained during active use when inflated).
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