510(k) K162193
K162193 is an FDA 510(k) premarket notification submitted by C. R. Bard for the device "XenMatrix AB Surgical Graft". The FDA issued a decision of Substantially Equivalent on December 23, 2016. The device falls under product code PIJ (Collagen Surgical Mesh Containing Drugs), a Class II device regulated under 21 CFR 878.3300. C. R. Bard has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2016
- Date Received
- August 4, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collagen Surgical Mesh Containing Drugs
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
Reinforcement of soft tissue where weakness exists.