HurriChem Device Kit

FDA 510(k) K222575 · Thermasolutions, LLC

Substantially Equivalent

510(k) numberK222575

Submission

Device name
HurriChem Device Kit
Applicant
Thermasolutions, LLC
White Bear Lake, MN, US
Received
August 25, 2022
Decision date
December 6, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GCJ – Laparoscope, General & Plastic Surgery
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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Questions and answers

When was HurriChem Device Kit cleared by the FDA?

HurriChem Device Kit (K222575) received a 510(k) decision of Substantially Equivalent on December 6, 2022, 103 days after the submission was received.

What is the product code of K222575?

The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.