XenMatrix AB Surgical Graft
FDA 510(k) clearance K162193 · decided 2016-12-23
Clearance details
- K-number
- K162193
- Device name
- XenMatrix AB Surgical Graft
- Applicant
- C. R. Bard
- Decision
- Substantially Equivalent
- Date received
- 2016-08-04
- Decision date
- 2016-12-23
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- PIJ
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Warwick, RI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| XenMatrix AB Surgical Graft (K151177) | C. R. Bard | 2015-07-30 |
| XENMATRIX AB SURGICAL GRAFT (K133223) | C.R. Bard, Inc. | 2014-09-19 |
Recalls involving this device
No recalls on record reference this clearance.