K223500 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 August 10, 2023, 262 days after receiving the submission on November 21, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K223500 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2022 |
| Decision Date | August 10, 2023 |
| Days to Decision | 262 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 |