K162193 is an FDA 510(k) clearance for the XenMatrix AB Surgical Graft. This device is classified as a Collagen Surgical Mesh Containing Drugs (Class II - Special Controls, product code PIJ).
Submitted by C. R. Bard (Warwick, US). The FDA issued a Cleared decision on December 23, 2016, 141 days after receiving the submission on August 4, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300. Reinforcement Of Soft Tissue Where Weakness Exists..
| 510(k) Number | K162193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2016 |
| Decision Date | December 23, 2016 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PIJ - Collagen Surgical Mesh Containing Drugs |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | Reinforcement Of Soft Tissue Where Weakness Exists. |