510(k) K181741
K181741 is an FDA 510(k) premarket notification submitted by Galil Medical , Ltd. for the device "IceSphere 1.5 CX Cryoablation Needle". The FDA issued a decision of Substantially Equivalent on July 30, 2018. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Galil Medical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2018
- Date Received
- July 2, 2018
- Clearance Type
- Special
- 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