K203081 is an FDA 510(k) clearance for the RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyester (Class II - Special Controls, product code GAS).
Submitted by Lsi Solutions (Victor, US). The FDA issued a Cleared decision on November 24, 2020, 42 days after receiving the submission on October 13, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K203081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 2020 |
| Decision Date | November 24, 2020 |
| Days to Decision | 42 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAS - Suture, Nonabsorbable, Synthetic, Polyester |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5000 |