510(k) K090202
K090202 is an FDA 510(k) premarket notification submitted by Ncontact Surgical, Inc. for the device "NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125". The FDA issued a decision of Substantially Equivalent on February 17, 2009. 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. Ncontact Surgical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2009
- Date Received
- January 27, 2009
- Clearance Type
- Special
- 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