510(k) K240776
K240776 is an FDA 510(k) premarket notification submitted by Endocision Technologies, Inc. for the device "Celsio Flexible Cryocatheter System". The FDA issued a decision of Substantially Equivalent on September 24, 2024. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 2024
- Date Received
- March 21, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Cryosurgical, Accessories
- Device Class
- Class II
- Regulation Number
- 878.4350
- Review Panel
- SU
- Submission Type