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510(k) Data Aggregation
K Number
K243367Device Name
Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
Manufacturer
Minnesota Medical Technologies
Date Cleared
2025-07-22
(265 days)
Product Code
PBP
Regulation Number
876.5980Why did this record match?
Product Code :
PBP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K122003Device Name
RENEW INSERT
Manufacturer
RENEW MEDICAL, INC.
Date Cleared
2012-10-26
(109 days)
Product Code
PBP
Regulation Number
876.5980Why did this record match?
Product Code :
PBP
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.
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