K231603 is an FDA 510(k) clearance for the Standard Staple-Line Reinforcement (SSLR23). This device is classified as a Mesh, Surgical, Absorbable, Staple Line Reinforcement (Class II - Special Controls, product code OXC).
Submitted by Standard Bariatrics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 6, 2023, 127 days after receiving the submission on June 1, 2023.
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 Staple Line Reinforcement Procedures..
| 510(k) Number | K231603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2023 |
| Decision Date | October 06, 2023 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OXC - Mesh, Surgical, Absorbable, Staple Line Reinforcement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures. |