510(k) K162388
K162388 is an FDA 510(k) premarket notification submitted by Curaseal, Inc. for the device "CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)". The FDA issued a decision of Substantially Equivalent on Feb 3, 2017. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 3, 2017
- Date Received
- Aug 25, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
- 510(k)