Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K122003
    Device Name
    RENEW INSERT
    Manufacturer
    RENEW MEDICAL, INC.
    Date Cleared
    2012-10-26

    (109 days)

    Product Code
    PBP
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    RENEW MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Renew Insert is indicated for the management of accidental bowel leakage due to bowel incontinence. The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.
    Device Description
    The Renew Insert is a simple, easy to use device consisting of two components: a soft silicone insert and a plastic fingertip applicator. The Insert is soft and easily deformable, making it safe and comfortable to use. The applicator is flexible and is preassembled inside the Insert and does not come in contact with the anal canal. Renew Inserts are available in two sizes, Regular and Large to accommodate a range of anatomies and incontinence severities. Users are instructed to start with the Regular size and move to the Large size if they experience an inadvertent loss of the Insert or stool leakage around the Insert. The device is provided and non-sterile in individual, single-use blister packs.
    Ask a Question

    Page 1 of 1