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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 the device name listed in this FDA 510(k) record. The listed applicant is Thermasolutions, LLC. It received FDA 510(k) clearance on 2022-12-06 under 510(k) 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. The listed applicant is Thermasolutions, LLC. The 510(k) number is K222575.

When did HurriChem Device Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for HurriChem Device Kit?

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 HurriChem Device Kit?

The FDA product code for HurriChem Device Kit is GCJ.

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.

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

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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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