C Change Surgical Warned for Selling Unapproved Device

C Change Surgical did not seek premarket approval or clearance for its IntraTemp solution warmer, which is used to control sterile fluid temperatures, before marketing or selling the device, according to an FDA warning letter. The agency also cites the company for making changes to the device’s electrical circuitry without submitting a new 510(k). C Change Surgical’s CEO Patrick Kammer said the company has addressed the issues and has requested a follow-up FDA inspection.
Devices & Diagnostics Letter