K180191 is an FDA 510(k) clearance for the SuperBall Meniscal Repair System. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II - Special Controls, product code GAT).
Submitted by Arcuro Medical , Ltd. (Misgav, IL). The FDA issued a Cleared decision on June 5, 2018, 133 days after receiving the submission on January 23, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K180191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2018 |
| Decision Date | June 05, 2018 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAT - Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5000 |