510(k) K183153
K183153 is an FDA 510(k) premarket notification submitted by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. for the device "Microwave Ablation System". The FDA issued a decision of Substantially Equivalent on July 8, 2019. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 2019
- Date Received
- November 14, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Ablation, Microwave And Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type