Fang Consulting is extremely happy to announce that it has assisted ThermaSolutions in receiving 510(k) authorization for their new HurriChem device.
ThermaSolutions developed the HurriChem, a unique aerosolization tool used in abdominal surgery procedures.
Our team at Fang Consulting helped organize the 510(k) submission resulting in the HurriChem device receiving authorization with only one request for additional information from the FDA, to clarify three simple questions.
ThermaSolutions, based in St. Paul, Minnesota, is the global leader in Hyperthermic Intraperitoneal Chemotherapy Technology. ThermaSolutions has been developing innovative medical devices since 1999, seeing their experienced team grow to 20 people as of early 2023.
“Without the regulatory support that Fang Consulting provided, we would not have been able to obtain 510(k) authorization from the FDA with only one round of questions that we were able to clear up in fifteen minutes,” Gregg Giza, Global Product Director of ThermaSolutions said.
Fang Consulting is a Regulatory Affairs and Engineering Services company based out of Roseville, Minnesota specializing in medical device consulting. Since 1999, Fang has helped countless companies navigate the complicated regulatory affairs processes in getting medical devices authorized by the FDA.
Contact us at 612.230.9909 to learn more and see if our consulting services can help your company with any FDA related issues.
Contact Gregg Giza, ThermaSolutions’ Global Product Director at 612.968.0454 to learn more about their Hyperthermic Medical Technologies and if the HurriChem device or any others could be a solution for your business.