Submission Details
| 510(k) Number | K243598 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 21, 2024 |
| Decision Date | July 13, 2025 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
K243598 is an FDA 510(k) clearance for the Welch Allyn Connex? 360 (Multiple), submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 13, 2025, 234 days after receiving the submission on November 21, 2024. This device falls under the Cardiovascular review panel.
| 510(k) Number | K243598 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 21, 2024 |
| Decision Date | July 13, 2025 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | — |
| Device Class | — |