PMA P230002

Device: Minitouch 3.8 Era System (Minitouch System)
Applicant: Microcube, LLC
Product code: MNB
Decision date: 2026-07-13
Generic name: Device, thermal ablation, endometrial
Approval order statement: Approval for design modifications to the Minitouch System, including changes to the Handpiece manufacturing methods and changes to the Generator system architecture, hardware, and software to add additional risk control measures and provide an updated user interface.

Current openFDA PMA Record#

Device: Minitouch 3.8 Era System (Minitouch System)
Applicant: Microcube, LLC
PMA number: P230002
Supplement: S002
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2026-07-13
Decision code: APPR
Date received: 2025-12-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for design modifications to the Minitouch System, including changes to the Handpiece manufacturing methods and changes to the Generator system architecture, hardware, and software to add additional risk control measures and provide an updated user interface.