K123128 is an FDA 510(k) clearance for the SERI SURGICAL SCAFFOLD. This device is classified as a Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery (Class II - Special Controls, product code OXF).
Submitted by Allergan (Medford, US). The FDA issued a Cleared decision on April 25, 2013, 203 days after receiving the submission on October 4, 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 In Plastic And Reconstructive Surgery..
| 510(k) Number | K123128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2012 |
| Decision Date | April 25, 2013 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OXF — Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery. |