510(k) K172769
K172769 is an FDA 510(k) premarket notification submitted by Cryoconcepts LP for the device "CryOmega Flexx". The FDA issued a decision of Substantially Equivalent on November 30, 2017. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Cryoconcepts LP has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2017
- Date Received
- September 13, 2017
- 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