K120728 is an FDA 510(k) clearance for the PHASIX PLUG AND PATCH. This device is classified as a Mesh, Surgical, Absorbable, Abdominal Hernia (Class II - Special Controls, product code OWT).
Submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on October 22, 2012, 227 days after receiving the submission on March 9, 2012.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists During Hernia Repair..
| 510(k) Number | K120728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2012 |
| Decision Date | October 22, 2012 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OWT — Mesh, Surgical, Absorbable, Abdominal Hernia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists During Hernia Repair. |