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# FDA Clears RevMedx Gun/Knife Wound Device
- URL: https://www.fdaweb.com/fda-clears-revmedx-gun-knife-wound-device/
- Published: 2017-08-23T12:00:00.000Z
- Updated: 2026-09-14T22:43:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139456

FDA has cleared a RevMedx 510(k) for the XSTAT 12 and XSTAT 30 hemostatic devices for controlling severe, life-threatening bleeding from narrow entrance extremity wounds. Previously limited to treating junctional wounds in the groin or shoulder area, XSTAT devices can now be used to treat severe bleeding from bullet or knife wounds located in an arm or leg, the company says.

The devices work by injecting a group of small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator. “In a wound, the sponges rapidly expand and exert hemostatic pressure,” the company says. “Unlike traditional methods that may take several minutes to be effective, XSTAT can stop bleeding in seconds to stabilize injuries until patients reach an emergency facility.”