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510(k) K122003

RENEW INSERT by Renew Medical, Inc. — Product Code PBP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 26, 2012
Date Received: July 9, 2012
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Rectal Insert
Device Class: Class II
Regulation Number: 876.5980
Review Panel: GU
Submission Type

Acts as a barrier to the passage of fecal matter through the rectum.