510(k) K113510
K113510 is an FDA 510(k) premarket notification submitted by Cook Ireland, Ltd. for the device "EVOLUTION COLONIC STENT SYSTEM". The FDA issued a decision of Substantially Equivalent on May 17, 2012. The device falls under product code MQR (Stent, Colonic, Metallic, Expandable), a Class II device regulated under 21 CFR 878.3610. Cook Ireland, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2012
- Date Received
- November 28, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stent, Colonic, Metallic, Expandable
- Device Class
- Class II
- Regulation Number
- 878.3610
- Review Panel
- GU
- Submission Type