510(k) K122003
K122003 is an FDA 510(k) premarket notification submitted by Renew Medical, Inc. for the device "RENEW INSERT". The FDA issued a decision of Substantially Equivalent on October 26, 2012. The device falls under product code PBP (Rectal Insert), a Class II device regulated under 21 CFR 876.5980.
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.