
Thermasolutions, LLC
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ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) is an FDA 510(k)-cleared medical device (K240447) manufactured by Thermasolutions, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 4, 2025. Regulation: 8.