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FDA 510(k)

HurriChem Device Kit

K-Number: K222575 · 2022-12-06

ApplicantThermasolutions, LLC
Decision Date2022-12-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HurriChem Device Kit is a medical device manufactured by Thermasolutions, LLC. It received FDA 510(k) clearance on 2022-12-06 under approval number K222575. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HurriChem Device Kit?

HurriChem Device Kit is a medical device that received FDA 510(k) clearance on 2022-12-06. It is manufactured by Thermasolutions, LLC. The 510(k) number is K222575.

When was HurriChem Device Kit approved by the FDA?

HurriChem Device Kit received FDA 510(k) clearance on 2022-12-06, under approval number K222575.

What company makes HurriChem Device Kit?

HurriChem Device Kit is manufactured by Thermasolutions, LLC.

What is the FDA product code for HurriChem Device Kit?

The FDA product code for HurriChem Device Kit is GCJ.

Other Devices by Thermasolutions, LLC

K240447ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)

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Official Source

View on FDA Database →

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

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