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# Teleflex Gains Expanded Use on QuikClot Device
- URL: https://www.fdaweb.com/teleflex-gains-expanded-use-on-quikclot-device/
- Published: 2025-05-06T12:00:00.000Z
- Updated: 2026-09-14T15:11:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159129

FDA has cleared a Teleflex 510(k) for an expanded indication for its QuikClot Control+ Hemostatic Device to include all grades of internal and external bleeding. The device was previously indicated for temporary control of Class III and Class IV internal organ space bleeding, severely bleeding surgical wounds, mild and moderate bleeding in cardiac surgical procedures, and bone surfaces following sternotomy.

To support the labeling change, Teleflex says it used real-world evidence from a retrospective, statistically powered, observational study of 603 emergency, trauma, and surgical patients. The study assessed the device’s ability to control all grades of bleeding in multiple and varied anatomical sites during surgical procedures and in bleeding due to injuries, it adds.