FDA 510(k) Submission Details - K260652
| 510(k) Number | K260652 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2026 |
| Decision Date | September 09, 2026 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Third-party Review | No - reviewed directly by FDA |
| Combination Product | No |
| PCCP Authorized | No |
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 115d · This submission: 194d
Pathway characteristics
Predicate-based equivalence.