Search Results
Found 1 results
510(k) Data Aggregation
K Number
K042431Device Name
PROCON2
Manufacturer
INCONTINENT CONTROL DEVICES, INC.
Date Cleared
2005-05-27
(261 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
INCONTINENT CONTROL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Procon 2 is a single use catheter with an inflatable balloon cuff intended to act as a barrier to the passage of fecal matter through the rectum.
Procon2 is for an individual with fecal incontinence that has impaired quality of life, is sufficiently motivated psychologically to participate in their own treatment, and having good manual dexterity is an ideal candidate. He or she is either not a surgical candidate or has not responded to conservative treatment.
Device Description
A single use rectal silicone catheter with a water filled cuff acting as a barrier to the unintended passage of feces through the rectum.
Ask a Question
Page 1 of 1