510(k) K150089
K150089 is an FDA 510(k) premarket notification submitted by AngioDynamics, Inc. for the device "NanoKnife System". The FDA issued a decision of Substantially Equivalent on June 18, 2015. The device falls under product code OAB (Low Energy Direct Current Thermal Ablation System), a Class II device regulated under 21 CFR 878.4400. AngioDynamics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2015
- Date Received
- January 16, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Low Energy Direct Current Thermal Ablation System
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
Ablation of soft tissue