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FDA 510(k)

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)

K-Number: K240447 · 2025-05-05

ApplicantThermasolutions, LLC
Decision Date2025-05-05
Product CodeMLW
Advisory CommitteeGU
DecisionUnknown

Device Summary

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) is the device name listed in this FDA 510(k) record. The listed applicant is Thermasolutions, LLC. It received FDA 510(k) clearance on 2025-05-05 under 510(k) number K240447. The device is classified under product code MLW. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)?

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) is a medical device that received FDA 510(k) clearance on 2025-05-05. The listed applicant is Thermasolutions, LLC. The 510(k) number is K240447.

When did ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) receive FDA 510(k) clearance?

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) received FDA 510(k) clearance on 2025-05-05, under 510(k) number K240447.

Who is the listed applicant for ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)?

The FDA 510(k) record lists Thermasolutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)?

The FDA product code for ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) is MLW.

Other records listing Thermasolutions, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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