ProSense System— 510(k) DEN220077

Unknown

Icecure Medical

FDA 510(k) clearance DEN220077 for ProSense System, Unknown on 2025-10-03. Applicant: Icecure Medical. Device class: 2.

Clearance details

Applicant
Icecure Medical
Product code
Code QXW
Device class
Class 2
Regulation
21 CFR 878.4355
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Unknown
Clearance type
Direct
Location
Caesarea, IL
View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.