510(k) K102329
K102329 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 October 24, 2011. 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
- October 24, 2011
- Date Received
- August 17, 2010
- 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