510(k) K102360
K102360 is an FDA 510(k) premarket notification submitted by IceCure Medical , Ltd. for the device "ICESENCE 3". The FDA issued a decision of Substantially Equivalent on November 29, 2010. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. IceCure Medical , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 2010
- Date Received
- August 19, 2010
- 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