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510(k) Data Aggregation
K Number
K213773Device Name
Insufflation Retention Device
Manufacturer
Date Cleared
2022-07-21
(231 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Bpendo, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Insufflation Retention Device (IRD) is an accessory to an endoscope. The IRD is a single balloon accessory intended for use with any standard endoscope that has a distal tip outer diameter of 9.2-13.2 mm. The device is indicated to assist with optical visualization in the large intestine during endoscopic procedures.
Device Description
The IRD is a non-sterile accessory for a colonoscope which provides an adjustable seal between a colonoscope and a patient's anus. This seal retains introduced insufflation air introduced during a colonoscopy. The retained insufflation air provides increased visibility and facilitates the advancement of the colonoscope. The IRD contains a split section which allows it to be placed over the continuous shaft of the colonoscope. The adjustable seal is inflated and deflated manually with a non-sterile syringe.
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