Cleared Traditional

K243598 - Welch Allyn Connex® 360 (Multiple) (FDA 510(k) Clearance)

Jul 2025
Decision
234d
Days
Risk

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 FDA review panel.

Submission Details

510(k) Number K243598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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

Device Classification

Product Code
Device Class