K161939 is an FDA 510(k) clearance for the Avance Abdominal Dressing Kit. This device is classified as a Mesh, Surgical, Non-absorbable, Large Abdominal Wall Defects (Class II - Special Controls, product code OXJ).
Submitted by Molnlycke Health Care Us, LLC (Norcross, US). The FDA issued a Cleared decision on November 17, 2016, 126 days after receiving the submission on July 14, 2016.
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 In Abdominal Wall Defects..
| 510(k) Number | K161939 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2016 |
| Decision Date | November 17, 2016 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OXJ — Mesh, Surgical, Non-absorbable, Large Abdominal Wall Defects |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists In Abdominal Wall Defects. |