HurriChem Device Kit: FDA 510(k) K222575 cleared 2022

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK222575	Date6 Dec 2022Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K222575

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K222575
FDA product code: GCJ

Device class: Class II
Regulation: 21 CFR Part 876.1500
Advisory committee: Gastroenterology, Urology
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Dannik Laparoscopic Suction Irrigation System K192643 19 Nov 2019 FDA record · FDA summary

Cited by

REGER Nebulizer Irrigation Cannula K231622 29 Sep 2023 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K222575

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K222575
		UDI-DI	Size and differences
HurriChem Device Kit PDT-5800 THERMASOLUTIONS, INC.	PDT-5800	00851450007299	Height 4.000 cm; Width 35.000 cm; Depth 15.000 cm	On the market

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, General & Plastic Surgery).

Other devices from Thermasolutions LLC.

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

Class II