510(k) K200514
K200514 is an FDA 510(k) premarket notification submitted by Medtronic for the device "Cardioblate Gemini-s Surgical Ablation Device". The FDA issued a decision of Substantially Equivalent on June 3, 2020. The device falls under product code OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue), a Class II device regulated under 21 CFR 878.4400. Medtronic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2020
- Date Received
- March 2, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- CV
- Submission Type
Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue