510(k) K253122
K253122 is an FDA 510(k) premarket notification submitted by Sim&Cure for the device "Sim&Size". The FDA issued a decision of Substantially Equivalent on December 23, 2025. The device falls under product code PZO (Software For Visualization Of Vascular Anatomy And Intravascular Devices), a Class II device regulated under 21 CFR 892.2050. Sim&Cure has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2025
- Date Received
- September 25, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Software For Visualization Of Vascular Anatomy And Intravascular Devices
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- CV
- Submission Type
Visualization and measurement of blood vessels and intravascular devices for preoperational planning.