K130852 is an FDA 510(k) clearance for the AVANCE? FOAM ABDOMINAL DRESSING KIT, a Mesh, Surgical, Non-absorbable, Large Abdominal Wall Defects (Class II — Special Controls, product code OXJ), submitted by Molnlycke Health Care (Norcross, US). The FDA issued a Cleared decision on April 14, 2014, 382 days after receiving the submission on March 28, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K130852 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 28, 2013 |
| Decision Date | April 14, 2014 |
| Days to Decision | 382 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. |