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510(k) DEN210027

The Cooral System by Braincool AB — Product Code QUA

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
October 14, 2022
Date Received
July 2, 2021
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intraoral Cooling Device
Device Class
Class II
Regulation Number
872.5590
Review Panel
DE
Submission Type

An intraoral cooling device is a prescription use device that is intended to cool the mouth for patients at risk for oral mucositis. An intraoral cooling device consists of a removable mouthpiece and accessories that cool oral mucosal surfaces

Other clearances by Braincool AB

  • K232844 — The IQoolTM System (October 4, 2023)
  • K180375 — The IQoolTM Warm System (May 18, 2018)
  • K162523 — The IQool System (May 3, 2017)

Other clearances for product code QUA

  • K232917 — Chemo Mouthpiece (January 23, 2024)