ProSense™ System
FDA 510(k) clearance DEN220077 · decided 2025-10-03
Clearance details
- K-number
- DEN220077
- Device name
- ProSense™ System
- Applicant
- Icecure Medical
- Decision
- Unknown
- Date received
- 2022-10-19
- Decision date
- 2025-10-03
- Days to decision
- 1080 days
- Clearance type
- Direct
- Product code
- QXW
- Device class
- 2
- Regulation number
- 878.4355
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Caesarea, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.