510(k) K163576
K163576 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "GORE SYNECOR Preperitoneal Biomaterial". The FDA issued a decision of Substantially Equivalent on May 11, 2017. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. W. L. Gore & Associates, Inc. has 165 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2017
- Date Received
- Dec 19, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Polymeric
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
- 510(k)