K242835 is an FDA 510(k) clearance for the Suture-TOOL System, a Suture, Surgical, Absorbable, Polydioxanone (Class II — Special Controls, product code NEW), submitted by Suturion AB (Lund, SE). The FDA issued a Cleared decision on January 22, 2025, 125 days after receiving the submission on September 19, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4840.
| 510(k) Number | K242835 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 19, 2024 |
| Decision Date | January 22, 2025 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEW — Suture, Surgical, Absorbable, Polydioxanone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4840 |