510(k) Report

Devices descending from K191760

2 later devices reach PICO 14 Single Use Negative Pressure Wound Therapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213906extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd.20231—
+2K251646extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices20250—