K190185 is an FDA 510(k) clearance for the Phasix ST Mesh with Open Positioning System. 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 June 12, 2019, 131 days after receiving the submission on February 1, 2019.
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 | K190185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2019 |
| Decision Date | June 12, 2019 |
| Days to Decision | 131 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. |