510(k) K163684
K163684 is an FDA 510(k) premarket notification submitted by C2 Therapeutics, Inc. for the device "C2 CryoBalloon Ablation System". The FDA issued a decision of Substantially Equivalent on January 23, 2018. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. C2 Therapeutics, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2018
- Date Received
- December 28, 2016
- 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