510(k) K163217
K163217 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "GORE BIO-A Tissue Reinforcement". The FDA issued a decision of Substantially Equivalent on February 10, 2017. The device falls under product code OXF (Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery), a Class II device regulated under 21 CFR 878.3300. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2017
- Date Received
- November 16, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.