510(k) K133223
K133223 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "XENMATRIX AB SURGICAL GRAFT". The FDA issued a decision of Substantially Equivalent on September 19, 2014. 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, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 2014
- Date Received
- October 21, 2013
- 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.